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Technique Manual
Foot&Ankle
Procedures
theworld’sfirstandonly
disposablecompressive 	
fixationsystem*
*patents pending
2
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
Dwyer Calcaneal
Closing Wedge
Valgus Osteotomy
Calcaneocuboid
Arthrodesis
Crescentic or Closing
Wedge Basal Osteotomy
Akin Osteotomy
Interphalangeal
Joint Arthrodesis
of the Great Toe
Chevron Osteotomy/
Bunionectomy
of the Distal First
Metatarsal
First
Metatarsocuneiform
Arthrodesis
Chevron Osteotomy
of the Distal
Fifth Metatarsal/
Bunionette Excision
Talonavicular
Arthrodesis
FeaturedProcedures*:
Chevron Osteotomy/
Bunionectomy
of the Distal First
Metatarsal
*Images above display additional procedures performed using the BME Speed™ implants. These include Cotton Osteotomy, Folwer Osteotomy,
Weil Osteotomy, Naviculocuneiform Arthrodesis, 2-5 Tarsometatarsal Arthrodesis (Lisfranc), Evans Calcaneal Osteotomy and Jones Fracture
Fixation. In addition, the image shows BME HammerLock® implants for interphalangeal joint arthrodeses of the lesser toes.
3
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
Table Of Contents
Introduction and Indications . . . . . . . . . . . . . . . . . . . .  4
Bony Anatomy of the Foot and Ankle . . . . . . . . . . .  4
Basics Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Typical Foot and Ankle Procedures Using the
Speed™:
1 Akin Osteotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . .  6
2 Chevron Osteotomy/Bunionectomy .
of the Distal First Metatarsal . . . . . . . . . . . . . . . . 7
3 Interphalangeal Joint Arthrodesis
of the Great Toe . . . . . . . . . . . . . . . . . . . . . . . . . . . .  8
4 First Metatarsophalangeal Joint
Arthrodesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5 Crescentic or Closing Wedge Basal .
Osteotomy of the First Metatarsal . . . . . . . . . . 10

6 First Metatarsocuneiform Arthrodesis . . . . . .  11
7 Talonavicular Arthrodesis* . . . . . . . . . . . . . . . . .  12
8 Calcaneocuboid Arthrodesis* . . . . . . . . . . . . . .  13
9 Dwyer Calcaneal Closing Wedge
Valgus Osteotomy . . . . . . . . . . . . . . . . . . . . . . . . .  14
10 Chevron Osteotomy of the Distal Fifth .
Metatarsal/Bunionette Excision . . . . . . . . . . . . 15
*Triple Arthrodesis: These procedures comprise the portions .
of a triple arthrodesis performed using Speed™ implants.
featuring:
FootAnkleProcedures
madeinusa
4
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
Introduction
The Speed™ Continuous Compression Nitinol Fixation System features a family of memory metal alloy implants for compressive
internal fixation packaged in single-use kits. This manual is intended as a user guide for BME Sales Representatives in support of
surgeons. The Speed™ has market clearance from the FDA for the indications listed below. The indications listed for each procedure
are not intended to be complete but are representative of the most common indications seen to date.
Indications: Small bone fragment adjunctive fixation. Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Contraindications: Comminuted bone surface that would militate against staple placement. Pathologic conditions of bone such as
osteopenia that would impair the ability to securely fix the implant. Foreign body sensitivity to metals including nickel. Where material
sensitivity is suspected, appropriate tests should be made prior to implantation. Warnings: The implants cannot be expected to
replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing in the
presence of nonunion, delayed union or incomplete healing. Therefore, it is important that immobilization of the treatment site using
routine methods (casting, splints, etc.) be maintained until bone healing has occurred (4-6 weeks). Reduction of the site should be
achieved and maintained prior to implanting the device. The compressive force of the staple closing should not be relied upon to
achieve closure or reduction of a fracture line. The SpeedTM
Nitinol Implant System has not been evaluated for safety and compatibility
in the MR environment. The device has not been tested for heating or migration in the MR environment. Any additional processing or
reprocessing of the implant may affect the shape memory properties of the nitinol, changing or otherwise reducing the effectiveness
of the implant. Removal: 1.Expose the site and the bridge of the implant. 2.Using forceps grasp the center of the implant and remove.
If the implant is recessed, then use an elevator to lift the implant bridge and then use forceps to remove the implant. If the implant is
solidly connected, cut the bridge with wire cutters and twist and remove each staple leg. European Representative: Emergo Europe
Molenstraat 15 • 2513 BH The Hague • 0434 The Netherlands • Tel: (31) (0) 70 345-8570 • Fax: (31) (0) 70 346-7299
Osseous Anatomy of the Foot and Ankle
Tibia
Calcaneus
Cuboid
Fifth Metatarsal
Fibula
Talus
Navicular
Intermediate Cuneiform
Lateral Cuneiform
Phalanges
Distal
Middle
Proximal
Medial
Cuneiform
Intermediate
Cuneiform
Lateral
Cuneiform
Cuboid
Calcaneus
Navicular
Talus
Tarsals
1 2 3 4 5
Metatarsals
5
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
Part Number
Bridge
Width*
Leg
Length*
Wire
Size*
Drill Bit
Kit
Bridge
Closure*
Max
Closure*
SE-0907 09 07 1.5x1.5 DK-200 1.0 3.8
SE-0910 09 10 1.5x1.5 DK-200 1.0 5.0
SE-1110 11 10 1.5x1.5 DK-200 1.0 5.4
SE-111513 11 15/13 1.5x1.5 DK-200 1.0 7.1
SE-1310 13 10 1.5x1.5 DK-200 1.0 5.5
SE-131513 13 15/13 1.5x1.5 DK-200 1.0 7.3
SE-1512 15 12 1.5x1.5 DK-200 1.0 6.4
SE-1515 15 15 2x2 DK-265 1.5 8.3
SE-1815 18 15 2x2 DK-265 1.5 8.0
SE-181815 18 18/15 2x2 DK-265 1.5 8.8
SE-1818 18 18 2x2 DK-265 1.5 9.8
SE-2015 20 15 2x2 DK-265 1.5 8.0
SE-2020 20 20 2x2 DK-265 1.5 10.8
SE-2520 25 20 2x2 DK-265 1.5 10.9
Part
Number
Drill Bit
Size
Drill Guide
Handle
Locator Pins Tamp
For Use With
Implant Kit:
DK-200 2.0mm Included 2 x LP-200 TP-200 SE-0907 to SE-1512
DK-265 2.65mm Included 2 x LP-265 TP-265 SE-1515 to SE-2520
drillbitkits
implantkits
*sizes in millimeters
Bridge
Width
Leg
Length
Constrained
Basic Steps*
measure bridge
drill holes
insert - twist - tamp
repeat
* detailed technique located in Instructions for Use package insert.
Scan for video
6
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
1
Akin Osteotomy
1 Expose the proximal phalanx, create the osteotomy,
and reflect the periosteum. Remove the appropriate
wedge of bone to correct the deformity, while
preserving a lateral cortical hinge. Note: Reciprocal
planing with a sagittal saw is useful in providing
progressive correction while minimizing uneven
surfaces.
2 Hold the osteotomy reduction manually or with a
temporary K-wire.
3 Remove osteophytes or bony prominences,
particularly along the proximal metaphysis, with a
rongeur to slightly recess the implant.
4 Measure for the implant bridge width using the
Implant Sizing Guide (SG-1). Ensure that each prong
is at least 4mm from the osteotomy line. Ideally, the
fusion line should bisect the distance between the
prongs of the Sizing Guide. For bicortical fixation,
select an implant with longer legs (SE-0910,
SE-111513, or SE-131513).
5 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
6 Attach the Drill Guide Tip (found in the Implant Kit) to
the Drill Guide Handle (found in the Drill Bit Kit).
7 While ensuring full reduction, align the drill guide
across the osteotomy. Ensure both prongs of the Drill
Guide are touching bone.
8 Drill the first hole using the supplied Drill Bit (found in
the Drill Bit Kit). The Drill Guide contains a positive
stop that corresponds to the length of the legs of the
chosen implant (or the longest leg of an asymmetric
implant).
9 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
10 While ensuring full reduction, drill the second hole.
Insert a Locator Pin into the second hole, if desired.
11 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
12 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
13 While stabilizing the distal segment of the osteotomy,
twist the stick in either direction to disengage it from
the implant and apply immediate compression.
14 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
15 Close using established surgical techniques.
Indications:
• Hallux valgus
• Hallux valgus interphalangeal pronation
deformity
Fixation is achieved with one implant placed
in the dorsomedial position. Although medial placement
may be used, dorsomedial may be more effective if the
anatomy has a pronounced metaphyseal flare. If medial
placement is desired, a diaphyseal osteotomy will minimize
implant prominence versus a metaphyseal osteotomy.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-0907 DK-200
SE-0910 DK-200
SE-1110 DK-200
SE-111513 DK-200
SE-1310 DK-200
SE-131513 DK-200
commonsizes
Scan for video
7
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
Chevron Osteotomy/
Bunionectomy of the
Distal First Metatarsal
2
Indications:
• Moderate hallux valgus without arthritis
• Moderately high I-II intermetatarsal
angle or metatarsus primus varus
Fixation is achieved with one implant: one implant
leg into each of the bone segments. Where a standard
chevron may facilitate dorsal placement, a long-
arm osteotomy may require medial or dorsomedial
placement.
1 Expose the distal metaphysis of the first metatarsal
and proximal phalanx.
2 Excise the osseous bunion.
3 Create a V-shaped chevron osteotomy proximal to
the cephalic vessels of the first metatarsal.
4 Shift the metatarsal head laterally until the desired
correction is achieved. Hold the osteotomy
reduction manually or with a temporary K-wire.
5 Remove osteophytes or bony prominences to create
a flat surface for the implant.
6 Measure for the implant bridge width using the
Implant Sizing Guide (SG-1). Ensure that each prong
is at least 4mm from the osteotomy so that the distal
implant leg is placed in the metatarsal head while
avoiding the apex of the osteotomy. For bicortical
fixation, select an implant with longer legs (SE-0910,
SE-111513, or SE-131513).
7 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
8 Attach the Drill Guide Tip (found in the Implant Kit) to
the Drill Guide Handle (found in the Drill Bit Kit).
9 While ensuring full reduction, align the drill guide
across the osteotomy. Ensure both prongs of the Drill
Guide are touching bone.
10 Drill the first hole using the supplied Drill Bit (found in
the Drill Bit Kit). The Drill Guide contains a positive stop
that corresponds to the length of the legs of the chosen
implant (or the longest leg of an asymmetric implant).
11 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
12 While ensuring full reduction, drill the second hole.
Insert a Locator Pin into the second hole, if desired.
13 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
14 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
15 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
16 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
17 Close using established surgical techniques.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-1110 DK-200
SE-111513 DK-200
SE-1310 DK-200
SE-131513 DK-200
SE-1512 DK-200
SE-1515 DK-265
commonsizes
Scan for video
8
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
3
Interphalangeal Joint
Arthrodesis of the Great Toe
Indications:
• Arthrosis
• Hallux Malleus
• Jones Tenosuspension
Fixation is achieved with two identical implants. One is
placed in the dorsomedial position and one is placed in
the dorsolateral position.
1 Expose the interphalangeal joint and provide
appropriate soft tissue release.
2 If performing the arthrodesis in conjunction with a
Jones tenosuspension, transpose the insertion of the
extensor hallucis longus onto the neck of the first
metatarsal.
3 Remove the residual cartilage and appropriate
subchondral bone from both joint surfaces and in
doing so, achieve the desired deformity correction.
4 Reduce the joint and hold the reduction manually or
with a temporary K-wire.
5 Remove osteophytes or bony prominences with a
rongeur to slightly recess the implant.
6 Measure for the implant bridge width using the
Implant Sizing Guide (SG-1). Ensure that each prong
is at least 4mm from the fusion line. Ideally, the
fusion line should bisect the distance between the
prongs of the Sizing Guide.
7 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
8 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit)..
9 While ensuring full reduction, align the Drill Guide
across the dorsomedial aspect of the fusion site.
Ensure both prongs of the Drill Guide are touching
bone.
10 Drill the first hole using the supplied Drill Bit (found in
the Drill Bit Kit). The Drill Guide contains a positive
stop that corresponds to the length of the legs of the
chosen implant (or the longest leg of an asymmetric
implant).
11 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
12 While ensuring full reduction, drill the second hole.
Insert a Locator Pin into the second hole, if desired.
13 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
14 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
15 Twist the stick in either direction to disengage it from
the implant and to apply immediate compression.
16 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
17 Repeat steps 8-15 for the dorsolateral implant.
18 Close using established surgical techniques.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-0907 DK-200
SE-0910 DK-200
SE-1110 DK-200
SE-1310 DK-200
commonsizes
9
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
4
First Metatarsophalangeal Joint
Arthrodesis
Indications:
• Degenerative arthrosis of the first
metatarsophalangeal joint or hallux rigidus
• Severe hallux valgus with arthrosis (e.g.,
rheumatoid foot)
Fixation is achieved with two implants, one placed
dorsally and one medially.
Expose the first metatarsophalangeal joint and
provide appropriate soft tissue release.
Remove the residual cartilage and appropriate
subchondral bone from the base of the proximal
phalanx and distal metatarsal and in doing so,
achieve the desired deformity correction.
Reduce the joint and hold the reduction manually or
with a temporary K-wire.
Remove dorsal and medial osteophytes or bony
prominences with a rongeur to slightly recess the
implants.
Measure for the bridge width of the dorsal implant
using the Implant Sizing Guide (SG-1). If the
resection is flat, the fusion line should bisect the
distance between the prongs of the Sizing Guide.
For cup-and-cone joint preparations, consider a
wider implant or a slightly more distal placement in
order to avoid drilling into the concavity. Ensure that
each prong is at least 5-6mm from the fusion line.
6 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
7 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit).
8 While ensuring full reduction, align the drill guide
dorsally, centered across the fusion site in line with
the longitudinal axis of the metatarsal.
5
4
3
2
1
Ensure both prongs of the Drill Guide are touching 	
bone.
9 Drill the first hole using the supplied Drill Bit (found in
the Drill Bit Kit). The Drill Guide contains a positive stop
that corresponds to the length of the legs of the chosen
implant (or the longest leg of an asymmetric implant).
10 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
11 While ensuring full reduction, drill the second hole.
Insert a Locator Pin into the second hole, if desired.
12 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
13 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
14 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
15 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
16 Repeat steps 5-15 for the second implant. In general,
this implant is placed medially, taking care to offset the
implant distally or proximally so as to avoid the legs of
the first implant.
17 Close using established surgical techniques.
commonsizes
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-1512 DK-200
SE-1515 DK-265
SE-1815 DK-265
SE-181815 DK-265
SE-1818 DK-265
SE-2015 DK-265
SE-2020 DK-265
10
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
5
Crescentic or Closing Wedge
Basal Osteotomy of the First
Metatarsal
Indications:
• Severe hallux valgus
• High I-II intermetatarsal angle or metatarsus
primus varus
Fixation is achieved with one implant placed in the dorsal
lateral position. If desired for further stability, a second
implant is placed in the dorsomedial position.
Expose the proximal metaphyseal-diaphyseal
junction of the first metatarsal.
Create an appropriate crescentic or lateral closing
wedge osteotomy to correct the metatarsus varus, as
desired.
Close the osteotomy with lateral movement
of the distal end of the first metatarsal.
Hold the osteotomy reduction manually or with a
temporary K-wire.
Remove osteophytes or bony prominences with a
rongeur to slightly recess the implant.
Measure for the bridge width of the dorsal implant
using the Implant Sizing Guide (SG-1). Ensure that
each prong is at least 4mm from the osteotomy line.
Ideally, the fusion line should bisect the distance
between the prongs of the Sizing Guide.
7 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
8 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit).
9 While ensuring full reduction, align the drill guide
across the osteotomy. Ensure both prongs of the
Drill Guide are touching bone.
6
5
4
3
2
1
10 Drill the first hole using the supplied Drill Bit (found in
the Drill Bit Kit). The Drill Guide contains a positive stop
that corresponds to the length of the legs of the chosen
implant (or the longest leg of an asymmetric implant).
11 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
12 While ensuring full reduction, drill the second hole.
Insert a Locator Pin into the second hole, if desired.
13 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
14 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
15 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
16 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
17 For added stability, a second implant may be placed in
the dorsomedial position. Repeat steps 6-16 being
careful offset the placement of this implant so as to
avoid the legs of the first implant.
18 Close using established surgical techniques.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-1512 DK-200
SE-1515 DK-265
SE-1815 DK-265
SE-181815 DK-265
SE-1818 DK-265
SE-2015 DK-265
SE-2020 DK-265
commonsizes
11
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
6
First Metatarsocuneiform
Arthrodesis or Lapidus Procedure
Indications:
• Arthrosis
• Severe hallux valgus with instability of the first
metatarso-medial cuneiform joint (hypermobile
first ray with medially inclined joint, seen in the
adolescent juvenile bunion)
• High I-II intermetatarsal angle (metatarsus
primus varus)
Fixation is achieved with two to three implants. The
primary implant should be placed first in the dorsomedial
position. The secondary implant should be placed
medially just inferior to the central axis. Additional
implants should then be placed in the medial or
dorsomedial position.
Prepare both the metatarsal base and medial
cuneiform by denuding the articular surfaces and
appropriate subchondral bone.
Reduce the joint to the desired position, correcting
any varus deformity, and hold the reduction
manually or with a temporary K-wire.
Remove osteophytes or bony prominences with a
rongeur to slightly recess the implant.
4 Measure for the bridge width of the dorsal implant
using the Implant Sizing Guide (SG-1). Ensure that
each prong is at least 5-6mm from the fusion line.
Ideally, the fusion line should bisect the distance
between the prongs of the Sizing Guide.
5 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
6 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit).
7 While ensuring full reduction, align the drill guide
3
2
1
dorsally along the fusion site in line with the
longitudinal axis of the first metatarsal. Ensure both
prongs of the Drill Guide are touching bone.
8 Drill the first hole into the base of the metatarsal using
the supplied Drill Bit (found in the Drill Bit Kit). The Drill
Guide contains a positive stop that corresponds to the
length of the legs of the chosen implant (or the longest
leg of an asymmetric implant).
9 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
10 While ensuring full reduction, drill the second hole into
the first cuneiform. Insert a Locator Pin into the second
hole, if desired.
11 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
12 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
13 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
14 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
15 Repeat steps 5-15 for each additional implant, taking
care to offset the implant distally or proximally so as to
avoid the legs of the first implant.
16 Close using established surgical techniques.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-1515 DK-265
SE-1815 DK-265
SE-181815 DK-265
SE-1818 DK-265
SE-2015 DK-265
SE-2020 DK-265
SE-2520 DK-265
commonsizes
12
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
7
Talonavicular Arthrodesis
Indications:
• Arthrosis
• As part of a Triple Arthrodesis
Fixation is achieved with two to three implants. One is
placed in the dorsomedial position and one is placed in
the medial position.
NOTE: For triple arthrodeses, fixation is usually achieved
by first fixing the subtalar joint with a cannulated screw,
followed by fixation of both the talonavicular and
calcaneocuboid joints.
1 Expose and open the talonavicular joint.
2 Excise the cartilage and appropriate subchondral
bone on each face of the joint to maximize the
fusion interface area.
3 Reduce the joint and hold the reduction manually,
with a temporary K-wire or with
a clamp.
4 Remove osteophytes or bony prominences with a
rongeur to slightly recess the implant.
5 Measure for the bridge width of the medial or
dorsomedial implant using the Implant Sizing Guide
(SG-1). Ensure that each prong is at least 5-6mm
from the fusion line. Ideally, the fusion line should
bisect the distance between the prongs of the Sizing
Guide, however consider a wider implant or a
slightly more distal placement in order to avoid
drilling into the concavity formed by the
talonavicular joint.
6 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
7 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit).
8 While ensuring full reduction, align the drill guide
dorsomedially across the fusion site. Ensure both
prongs of the Drill Guide are touching bone.
9 Drill the first hole in the navicular using the supplied
Drill Bit (found in the Drill Bit Kit). The Drill Guide
contains a positive stop that corresponds to the length
of the legs of the chosen implant (or the longest leg of
an asymmetric implant).
10 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
11 While ensuring full reduction, drill the second hole into
the talus. Insert a Locator Pin into the second hole, if
desired.
12 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
13 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
14 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
15 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
16 Repeat steps 5-15 for each additional implant, taking
care to offset the implant distally or proximally so as to
avoid the legs of the first implant.
17 Close using established surgical techniques.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-1515 DK-265
SE-1815 DK-265
SE-181815 DK-265
SE-1818 DK-265
SE-2015 DK-265
SE-2020 DK-265
SE-2520 DK-265
commonsizes
13
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
8
Calcaneocuboid Arthrodesis
Indications:
• Arthrosis
• Forefoot abduction deformity in the painful
flatfoot
• As part of a Triple Arthrodesis
Fixation is achieved with two implants. One is placed in
the dorsal or dorsolateral position and one is placed in
the lateral position.
NOTE: For triple arthrodeses, fixation is usually achieved
by first fixing the subtalar joint with a cannulated screw,
followed by fixation of both the talonavicular and
calcaneocuboid joints. 8 While ensuring full reduction, align the drill guide
laterally across the fusion site. Ensure both prongs of
the Drill Guide are touching bone.
9 Drill the first hole in the calcaneus using the supplied
Drill Bit (found in the Drill Bit Kit). The Drill Guide
contains a positive stop that corresponds to the length
of the legs of the chosen implant (or the longest leg of
an asymmetric implant).
10 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
11 While ensuring full reduction, drill the second hole into
the cuboid. Insert a Locator Pin into the second hole, if
desired.
12 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
13 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
14 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
15 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
14 Repeat steps 5-15 for the dorsal implant, taking care to
offset the implant distally or proximally so as to avoid
the legs of the first implant.
16 Close using established surgical techniques.
1 Expose the lateral and dorsal margins of the
calcaneocuboid joint through a dorsal lateral
incision.
2 Excise the cartilage and appropriate subchondral
bone on each face of the joint to maximize the fusion
interface area.
3 Reduce the joint and hold the reduction manually,
with a temporary K-wire or with
a clamp.
3 Remove osteophytes or bony prominences with a
rongeur to slightly recess the implant.
5 Measure for the bridge width of the lateral implant
using the Implant Sizing Guide (SG-1). Ensure that
each prong is at least 5-6mm from the fusion line.
Ideally, the fusion line should bisect the distance
between the prongs of the Sizing Guide.
6 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
7 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit).
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-1515 DK-265
SE-1815 DK-265
SE-181815 DK-265
SE-1818 DK-265
SE-2015 DK-265
SE-2020 DK-265
SE-2520 DK-265
commonsizes
14
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
8 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
9 While ensuring full reduction, drill the second hole.
Insert a Locator Pin into the second hole, if desired.
10 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
11 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
12 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
13 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
14 Repeat steps 5-15 for the second implant.
15 Close using established surgical techniques.
Dwyer Calcaneal Closing
Wedge Valgus Osteotomy
Following exposure of the lateral aspect of the
calcaneus and creation of the desired V-shaped
osteotomy, close the osteotomy and fix the
calcaneus with one or more temporary K-wires or a
clamp.
Remove osteophytes or bony prominences with a
rongeur to slightly recess the implant.
3 Measure for the implant bridge width using the
Implant Sizing Guide (SG-1). Ensure that each prong
is at least 4mm from the osteotomy line. Ideally, the
fusion line should bisect the distance between the
prongs of the Sizing Guide.
4 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
5 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit).
6 While ensuring full reduction, align the drill guide
across the osteotomy. Ensure both prongs of the
Drill Guide are touching bone.
7 Drill the first hole using the supplied Drill Bit (found
in the Drill Bit Kit). The Drill Guide contains a positive
stop that corresponds to the length of the legs of the
chosen implant (or the longest leg of an asymmetric
implant).
2
1
9
Indications:
• Hindfoot varus deformity
Fixation is achieved with two implants placed laterally
across the osteotomy line.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-1515 DK-265
SE-1815 DK-265
SE-181815 DK-265
SE-1818 DK-265
SE-2015 DK-265
SE-2020 DK-265
SE-2520 DK-265
commonsizes
15
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint
or osteotomy at the time of exposure.
10
Chevron Osteotomy of the Distal
Fifth Metatarsal/Bunionette
Excision
Expose the dorsolateral aspect of the distal fifth
metatarsal.
Excise the osseous bunion.
Create a distal transverse osteotomy and resect
appropriate bone to achieve the desired deformity
correction.
Displace the distal fifth metatarsal head medially if
desired.
Hold the osteotomy reduction manually or with a
temporary K-wire.
Remove osteophytes or bony prominences with a
rongeur to slightly recess the implant.
Measure for the implant bridge width using the
Implant Sizing Guide (SG-1). Ensure that each prong
is at least 3-4mm from the osteotomy line. Ideally,
the osteotomy line should bisect the distance
between the prongs of the Sizing Guide.
8 Open the chosen Implant Kit and its corresponding
Drill Bit Kit.
9 Attach the Drill Guide Tip (found in the Implant Kit)
to the Drill Guide Handle (found in the Drill Bit Kit).
10 While ensuring full reduction, align the drill guide
across the osteotomy. Ensure both prongs of the
Drill Guide are touching bone.
11 Drill the first hole using the supplied Drill Bit (found
in the Drill Bit Kit). The Drill Guide contains a
positive stop that corresponds to the length of the
legs of the chosen implant (or the longest leg of an
asymmetric implant).
7
6
5
3
4
2
Indications:
• Bunionette deformity
• High IV-V intermetatarsal angle.
Fixation is achieved with one implant placed in the lateral
or dorsolateral position.
1
12 Insert a Locator Pin (found in the Drill Bit Kit) into the
first hole.
13 While ensuring full reduction, drill the second hole.
Insert a Locator Pin into the second hole, if desired.
14 Remove the Drill Guide. Locator Pin(s) may be left in
place to facilitate finding the drill holes.
15 Insert the Speed implant into the drill holes until the
storage/insertion stick is fully seated against bone.
Fluoroscopy may be used at this point to verify
placement.
16 Twist the stick in either direction to disengage it from
the implant and apply immediate compression.
17 Use the Tamp (found in the Drill Bit Kit) to fully seat the
implant.
18 Close using established surgical techniques.
Speed™ Implant Kit Corresponding Drill Bit Kit
SE-0907 DK-200
SE-0910 DK-200
SE-1110 DK-200
commonsizes
BioMedical Enterprises, Inc.
14785 Omicron Dr., Ste. 205 • San Antonio, Texas 78245
Phone: (210) 677-0354 • Fax: (866) 913-3977
Customer Service: (800) 880-6528
www.bme-tx.com • email: sales@bme-tx.com
FDA Cleared. CE Marked. Patents Pending.A120-014 (Rev 1)
0434
©2012 BioMedical Enterprises, Inc.
All rights reserved. Speed is a trademark
of BioMedical Enterprises, Inc.
madeinusa

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A staple

  • 2. 2 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. Dwyer Calcaneal Closing Wedge Valgus Osteotomy Calcaneocuboid Arthrodesis Crescentic or Closing Wedge Basal Osteotomy Akin Osteotomy Interphalangeal Joint Arthrodesis of the Great Toe Chevron Osteotomy/ Bunionectomy of the Distal First Metatarsal First Metatarsocuneiform Arthrodesis Chevron Osteotomy of the Distal Fifth Metatarsal/ Bunionette Excision Talonavicular Arthrodesis FeaturedProcedures*: Chevron Osteotomy/ Bunionectomy of the Distal First Metatarsal *Images above display additional procedures performed using the BME Speed™ implants. These include Cotton Osteotomy, Folwer Osteotomy, Weil Osteotomy, Naviculocuneiform Arthrodesis, 2-5 Tarsometatarsal Arthrodesis (Lisfranc), Evans Calcaneal Osteotomy and Jones Fracture Fixation. In addition, the image shows BME HammerLock® implants for interphalangeal joint arthrodeses of the lesser toes.
  • 3. 3 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. Table Of Contents Introduction and Indications . . . . . . . . . . . . . . . . . . . . 4 Bony Anatomy of the Foot and Ankle . . . . . . . . . . . 4 Basics Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Typical Foot and Ankle Procedures Using the Speed™: 1 Akin Osteotomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2 Chevron Osteotomy/Bunionectomy . of the Distal First Metatarsal . . . . . . . . . . . . . . . . 7 3 Interphalangeal Joint Arthrodesis of the Great Toe . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4 First Metatarsophalangeal Joint Arthrodesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5 Crescentic or Closing Wedge Basal . Osteotomy of the First Metatarsal . . . . . . . . . . 10 6 First Metatarsocuneiform Arthrodesis . . . . . . 11 7 Talonavicular Arthrodesis* . . . . . . . . . . . . . . . . . 12 8 Calcaneocuboid Arthrodesis* . . . . . . . . . . . . . . 13 9 Dwyer Calcaneal Closing Wedge Valgus Osteotomy . . . . . . . . . . . . . . . . . . . . . . . . . 14 10 Chevron Osteotomy of the Distal Fifth . Metatarsal/Bunionette Excision . . . . . . . . . . . . 15 *Triple Arthrodesis: These procedures comprise the portions . of a triple arthrodesis performed using Speed™ implants. featuring: FootAnkleProcedures madeinusa
  • 4. 4 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. Introduction The Speed™ Continuous Compression Nitinol Fixation System features a family of memory metal alloy implants for compressive internal fixation packaged in single-use kits. This manual is intended as a user guide for BME Sales Representatives in support of surgeons. The Speed™ has market clearance from the FDA for the indications listed below. The indications listed for each procedure are not intended to be complete but are representative of the most common indications seen to date. Indications: Small bone fragment adjunctive fixation. Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Contraindications: Comminuted bone surface that would militate against staple placement. Pathologic conditions of bone such as osteopenia that would impair the ability to securely fix the implant. Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation. Warnings: The implants cannot be expected to replace normal healthy bone or withstand the stress placed upon the device by full or partial weight bearing or load bearing in the presence of nonunion, delayed union or incomplete healing. Therefore, it is important that immobilization of the treatment site using routine methods (casting, splints, etc.) be maintained until bone healing has occurred (4-6 weeks). Reduction of the site should be achieved and maintained prior to implanting the device. The compressive force of the staple closing should not be relied upon to achieve closure or reduction of a fracture line. The SpeedTM Nitinol Implant System has not been evaluated for safety and compatibility in the MR environment. The device has not been tested for heating or migration in the MR environment. Any additional processing or reprocessing of the implant may affect the shape memory properties of the nitinol, changing or otherwise reducing the effectiveness of the implant. Removal: 1.Expose the site and the bridge of the implant. 2.Using forceps grasp the center of the implant and remove. If the implant is recessed, then use an elevator to lift the implant bridge and then use forceps to remove the implant. If the implant is solidly connected, cut the bridge with wire cutters and twist and remove each staple leg. European Representative: Emergo Europe Molenstraat 15 • 2513 BH The Hague • 0434 The Netherlands • Tel: (31) (0) 70 345-8570 • Fax: (31) (0) 70 346-7299 Osseous Anatomy of the Foot and Ankle Tibia Calcaneus Cuboid Fifth Metatarsal Fibula Talus Navicular Intermediate Cuneiform Lateral Cuneiform Phalanges Distal Middle Proximal Medial Cuneiform Intermediate Cuneiform Lateral Cuneiform Cuboid Calcaneus Navicular Talus Tarsals 1 2 3 4 5 Metatarsals
  • 5. 5 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. Part Number Bridge Width* Leg Length* Wire Size* Drill Bit Kit Bridge Closure* Max Closure* SE-0907 09 07 1.5x1.5 DK-200 1.0 3.8 SE-0910 09 10 1.5x1.5 DK-200 1.0 5.0 SE-1110 11 10 1.5x1.5 DK-200 1.0 5.4 SE-111513 11 15/13 1.5x1.5 DK-200 1.0 7.1 SE-1310 13 10 1.5x1.5 DK-200 1.0 5.5 SE-131513 13 15/13 1.5x1.5 DK-200 1.0 7.3 SE-1512 15 12 1.5x1.5 DK-200 1.0 6.4 SE-1515 15 15 2x2 DK-265 1.5 8.3 SE-1815 18 15 2x2 DK-265 1.5 8.0 SE-181815 18 18/15 2x2 DK-265 1.5 8.8 SE-1818 18 18 2x2 DK-265 1.5 9.8 SE-2015 20 15 2x2 DK-265 1.5 8.0 SE-2020 20 20 2x2 DK-265 1.5 10.8 SE-2520 25 20 2x2 DK-265 1.5 10.9 Part Number Drill Bit Size Drill Guide Handle Locator Pins Tamp For Use With Implant Kit: DK-200 2.0mm Included 2 x LP-200 TP-200 SE-0907 to SE-1512 DK-265 2.65mm Included 2 x LP-265 TP-265 SE-1515 to SE-2520 drillbitkits implantkits *sizes in millimeters Bridge Width Leg Length Constrained Basic Steps* measure bridge drill holes insert - twist - tamp repeat * detailed technique located in Instructions for Use package insert. Scan for video
  • 6. 6 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 1 Akin Osteotomy 1 Expose the proximal phalanx, create the osteotomy, and reflect the periosteum. Remove the appropriate wedge of bone to correct the deformity, while preserving a lateral cortical hinge. Note: Reciprocal planing with a sagittal saw is useful in providing progressive correction while minimizing uneven surfaces. 2 Hold the osteotomy reduction manually or with a temporary K-wire. 3 Remove osteophytes or bony prominences, particularly along the proximal metaphysis, with a rongeur to slightly recess the implant. 4 Measure for the implant bridge width using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 4mm from the osteotomy line. Ideally, the fusion line should bisect the distance between the prongs of the Sizing Guide. For bicortical fixation, select an implant with longer legs (SE-0910, SE-111513, or SE-131513). 5 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 6 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 7 While ensuring full reduction, align the drill guide across the osteotomy. Ensure both prongs of the Drill Guide are touching bone. 8 Drill the first hole using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 9 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 10 While ensuring full reduction, drill the second hole. Insert a Locator Pin into the second hole, if desired. 11 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 12 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 13 While stabilizing the distal segment of the osteotomy, twist the stick in either direction to disengage it from the implant and apply immediate compression. 14 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 15 Close using established surgical techniques. Indications: • Hallux valgus • Hallux valgus interphalangeal pronation deformity Fixation is achieved with one implant placed in the dorsomedial position. Although medial placement may be used, dorsomedial may be more effective if the anatomy has a pronounced metaphyseal flare. If medial placement is desired, a diaphyseal osteotomy will minimize implant prominence versus a metaphyseal osteotomy. Speed™ Implant Kit Corresponding Drill Bit Kit SE-0907 DK-200 SE-0910 DK-200 SE-1110 DK-200 SE-111513 DK-200 SE-1310 DK-200 SE-131513 DK-200 commonsizes Scan for video
  • 7. 7 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. Chevron Osteotomy/ Bunionectomy of the Distal First Metatarsal 2 Indications: • Moderate hallux valgus without arthritis • Moderately high I-II intermetatarsal angle or metatarsus primus varus Fixation is achieved with one implant: one implant leg into each of the bone segments. Where a standard chevron may facilitate dorsal placement, a long- arm osteotomy may require medial or dorsomedial placement. 1 Expose the distal metaphysis of the first metatarsal and proximal phalanx. 2 Excise the osseous bunion. 3 Create a V-shaped chevron osteotomy proximal to the cephalic vessels of the first metatarsal. 4 Shift the metatarsal head laterally until the desired correction is achieved. Hold the osteotomy reduction manually or with a temporary K-wire. 5 Remove osteophytes or bony prominences to create a flat surface for the implant. 6 Measure for the implant bridge width using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 4mm from the osteotomy so that the distal implant leg is placed in the metatarsal head while avoiding the apex of the osteotomy. For bicortical fixation, select an implant with longer legs (SE-0910, SE-111513, or SE-131513). 7 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 8 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 9 While ensuring full reduction, align the drill guide across the osteotomy. Ensure both prongs of the Drill Guide are touching bone. 10 Drill the first hole using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 11 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 12 While ensuring full reduction, drill the second hole. Insert a Locator Pin into the second hole, if desired. 13 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 14 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 15 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 16 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 17 Close using established surgical techniques. Speed™ Implant Kit Corresponding Drill Bit Kit SE-1110 DK-200 SE-111513 DK-200 SE-1310 DK-200 SE-131513 DK-200 SE-1512 DK-200 SE-1515 DK-265 commonsizes Scan for video
  • 8. 8 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 3 Interphalangeal Joint Arthrodesis of the Great Toe Indications: • Arthrosis • Hallux Malleus • Jones Tenosuspension Fixation is achieved with two identical implants. One is placed in the dorsomedial position and one is placed in the dorsolateral position. 1 Expose the interphalangeal joint and provide appropriate soft tissue release. 2 If performing the arthrodesis in conjunction with a Jones tenosuspension, transpose the insertion of the extensor hallucis longus onto the neck of the first metatarsal. 3 Remove the residual cartilage and appropriate subchondral bone from both joint surfaces and in doing so, achieve the desired deformity correction. 4 Reduce the joint and hold the reduction manually or with a temporary K-wire. 5 Remove osteophytes or bony prominences with a rongeur to slightly recess the implant. 6 Measure for the implant bridge width using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 4mm from the fusion line. Ideally, the fusion line should bisect the distance between the prongs of the Sizing Guide. 7 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 8 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit).. 9 While ensuring full reduction, align the Drill Guide across the dorsomedial aspect of the fusion site. Ensure both prongs of the Drill Guide are touching bone. 10 Drill the first hole using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 11 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 12 While ensuring full reduction, drill the second hole. Insert a Locator Pin into the second hole, if desired. 13 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 14 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 15 Twist the stick in either direction to disengage it from the implant and to apply immediate compression. 16 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 17 Repeat steps 8-15 for the dorsolateral implant. 18 Close using established surgical techniques. Speed™ Implant Kit Corresponding Drill Bit Kit SE-0907 DK-200 SE-0910 DK-200 SE-1110 DK-200 SE-1310 DK-200 commonsizes
  • 9. 9 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 4 First Metatarsophalangeal Joint Arthrodesis Indications: • Degenerative arthrosis of the first metatarsophalangeal joint or hallux rigidus • Severe hallux valgus with arthrosis (e.g., rheumatoid foot) Fixation is achieved with two implants, one placed dorsally and one medially. Expose the first metatarsophalangeal joint and provide appropriate soft tissue release. Remove the residual cartilage and appropriate subchondral bone from the base of the proximal phalanx and distal metatarsal and in doing so, achieve the desired deformity correction. Reduce the joint and hold the reduction manually or with a temporary K-wire. Remove dorsal and medial osteophytes or bony prominences with a rongeur to slightly recess the implants. Measure for the bridge width of the dorsal implant using the Implant Sizing Guide (SG-1). If the resection is flat, the fusion line should bisect the distance between the prongs of the Sizing Guide. For cup-and-cone joint preparations, consider a wider implant or a slightly more distal placement in order to avoid drilling into the concavity. Ensure that each prong is at least 5-6mm from the fusion line. 6 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 7 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 8 While ensuring full reduction, align the drill guide dorsally, centered across the fusion site in line with the longitudinal axis of the metatarsal. 5 4 3 2 1 Ensure both prongs of the Drill Guide are touching bone. 9 Drill the first hole using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 10 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 11 While ensuring full reduction, drill the second hole. Insert a Locator Pin into the second hole, if desired. 12 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 13 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 14 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 15 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 16 Repeat steps 5-15 for the second implant. In general, this implant is placed medially, taking care to offset the implant distally or proximally so as to avoid the legs of the first implant. 17 Close using established surgical techniques. commonsizes Speed™ Implant Kit Corresponding Drill Bit Kit SE-1512 DK-200 SE-1515 DK-265 SE-1815 DK-265 SE-181815 DK-265 SE-1818 DK-265 SE-2015 DK-265 SE-2020 DK-265
  • 10. 10 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 5 Crescentic or Closing Wedge Basal Osteotomy of the First Metatarsal Indications: • Severe hallux valgus • High I-II intermetatarsal angle or metatarsus primus varus Fixation is achieved with one implant placed in the dorsal lateral position. If desired for further stability, a second implant is placed in the dorsomedial position. Expose the proximal metaphyseal-diaphyseal junction of the first metatarsal. Create an appropriate crescentic or lateral closing wedge osteotomy to correct the metatarsus varus, as desired. Close the osteotomy with lateral movement of the distal end of the first metatarsal. Hold the osteotomy reduction manually or with a temporary K-wire. Remove osteophytes or bony prominences with a rongeur to slightly recess the implant. Measure for the bridge width of the dorsal implant using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 4mm from the osteotomy line. Ideally, the fusion line should bisect the distance between the prongs of the Sizing Guide. 7 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 8 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 9 While ensuring full reduction, align the drill guide across the osteotomy. Ensure both prongs of the Drill Guide are touching bone. 6 5 4 3 2 1 10 Drill the first hole using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 11 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 12 While ensuring full reduction, drill the second hole. Insert a Locator Pin into the second hole, if desired. 13 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 14 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 15 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 16 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 17 For added stability, a second implant may be placed in the dorsomedial position. Repeat steps 6-16 being careful offset the placement of this implant so as to avoid the legs of the first implant. 18 Close using established surgical techniques. Speed™ Implant Kit Corresponding Drill Bit Kit SE-1512 DK-200 SE-1515 DK-265 SE-1815 DK-265 SE-181815 DK-265 SE-1818 DK-265 SE-2015 DK-265 SE-2020 DK-265 commonsizes
  • 11. 11 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 6 First Metatarsocuneiform Arthrodesis or Lapidus Procedure Indications: • Arthrosis • Severe hallux valgus with instability of the first metatarso-medial cuneiform joint (hypermobile first ray with medially inclined joint, seen in the adolescent juvenile bunion) • High I-II intermetatarsal angle (metatarsus primus varus) Fixation is achieved with two to three implants. The primary implant should be placed first in the dorsomedial position. The secondary implant should be placed medially just inferior to the central axis. Additional implants should then be placed in the medial or dorsomedial position. Prepare both the metatarsal base and medial cuneiform by denuding the articular surfaces and appropriate subchondral bone. Reduce the joint to the desired position, correcting any varus deformity, and hold the reduction manually or with a temporary K-wire. Remove osteophytes or bony prominences with a rongeur to slightly recess the implant. 4 Measure for the bridge width of the dorsal implant using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 5-6mm from the fusion line. Ideally, the fusion line should bisect the distance between the prongs of the Sizing Guide. 5 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 6 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 7 While ensuring full reduction, align the drill guide 3 2 1 dorsally along the fusion site in line with the longitudinal axis of the first metatarsal. Ensure both prongs of the Drill Guide are touching bone. 8 Drill the first hole into the base of the metatarsal using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 9 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 10 While ensuring full reduction, drill the second hole into the first cuneiform. Insert a Locator Pin into the second hole, if desired. 11 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 12 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 13 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 14 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 15 Repeat steps 5-15 for each additional implant, taking care to offset the implant distally or proximally so as to avoid the legs of the first implant. 16 Close using established surgical techniques. Speed™ Implant Kit Corresponding Drill Bit Kit SE-1515 DK-265 SE-1815 DK-265 SE-181815 DK-265 SE-1818 DK-265 SE-2015 DK-265 SE-2020 DK-265 SE-2520 DK-265 commonsizes
  • 12. 12 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 7 Talonavicular Arthrodesis Indications: • Arthrosis • As part of a Triple Arthrodesis Fixation is achieved with two to three implants. One is placed in the dorsomedial position and one is placed in the medial position. NOTE: For triple arthrodeses, fixation is usually achieved by first fixing the subtalar joint with a cannulated screw, followed by fixation of both the talonavicular and calcaneocuboid joints. 1 Expose and open the talonavicular joint. 2 Excise the cartilage and appropriate subchondral bone on each face of the joint to maximize the fusion interface area. 3 Reduce the joint and hold the reduction manually, with a temporary K-wire or with a clamp. 4 Remove osteophytes or bony prominences with a rongeur to slightly recess the implant. 5 Measure for the bridge width of the medial or dorsomedial implant using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 5-6mm from the fusion line. Ideally, the fusion line should bisect the distance between the prongs of the Sizing Guide, however consider a wider implant or a slightly more distal placement in order to avoid drilling into the concavity formed by the talonavicular joint. 6 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 7 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 8 While ensuring full reduction, align the drill guide dorsomedially across the fusion site. Ensure both prongs of the Drill Guide are touching bone. 9 Drill the first hole in the navicular using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 10 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 11 While ensuring full reduction, drill the second hole into the talus. Insert a Locator Pin into the second hole, if desired. 12 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 13 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 14 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 15 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 16 Repeat steps 5-15 for each additional implant, taking care to offset the implant distally or proximally so as to avoid the legs of the first implant. 17 Close using established surgical techniques. Speed™ Implant Kit Corresponding Drill Bit Kit SE-1515 DK-265 SE-1815 DK-265 SE-181815 DK-265 SE-1818 DK-265 SE-2015 DK-265 SE-2020 DK-265 SE-2520 DK-265 commonsizes
  • 13. 13 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 8 Calcaneocuboid Arthrodesis Indications: • Arthrosis • Forefoot abduction deformity in the painful flatfoot • As part of a Triple Arthrodesis Fixation is achieved with two implants. One is placed in the dorsal or dorsolateral position and one is placed in the lateral position. NOTE: For triple arthrodeses, fixation is usually achieved by first fixing the subtalar joint with a cannulated screw, followed by fixation of both the talonavicular and calcaneocuboid joints. 8 While ensuring full reduction, align the drill guide laterally across the fusion site. Ensure both prongs of the Drill Guide are touching bone. 9 Drill the first hole in the calcaneus using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 10 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 11 While ensuring full reduction, drill the second hole into the cuboid. Insert a Locator Pin into the second hole, if desired. 12 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 13 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 14 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 15 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 14 Repeat steps 5-15 for the dorsal implant, taking care to offset the implant distally or proximally so as to avoid the legs of the first implant. 16 Close using established surgical techniques. 1 Expose the lateral and dorsal margins of the calcaneocuboid joint through a dorsal lateral incision. 2 Excise the cartilage and appropriate subchondral bone on each face of the joint to maximize the fusion interface area. 3 Reduce the joint and hold the reduction manually, with a temporary K-wire or with a clamp. 3 Remove osteophytes or bony prominences with a rongeur to slightly recess the implant. 5 Measure for the bridge width of the lateral implant using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 5-6mm from the fusion line. Ideally, the fusion line should bisect the distance between the prongs of the Sizing Guide. 6 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 7 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). Speed™ Implant Kit Corresponding Drill Bit Kit SE-1515 DK-265 SE-1815 DK-265 SE-181815 DK-265 SE-1818 DK-265 SE-2015 DK-265 SE-2020 DK-265 SE-2520 DK-265 commonsizes
  • 14. 14 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 8 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 9 While ensuring full reduction, drill the second hole. Insert a Locator Pin into the second hole, if desired. 10 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 11 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 12 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 13 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 14 Repeat steps 5-15 for the second implant. 15 Close using established surgical techniques. Dwyer Calcaneal Closing Wedge Valgus Osteotomy Following exposure of the lateral aspect of the calcaneus and creation of the desired V-shaped osteotomy, close the osteotomy and fix the calcaneus with one or more temporary K-wires or a clamp. Remove osteophytes or bony prominences with a rongeur to slightly recess the implant. 3 Measure for the implant bridge width using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 4mm from the osteotomy line. Ideally, the fusion line should bisect the distance between the prongs of the Sizing Guide. 4 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 5 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 6 While ensuring full reduction, align the drill guide across the osteotomy. Ensure both prongs of the Drill Guide are touching bone. 7 Drill the first hole using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 2 1 9 Indications: • Hindfoot varus deformity Fixation is achieved with two implants placed laterally across the osteotomy line. Speed™ Implant Kit Corresponding Drill Bit Kit SE-1515 DK-265 SE-1815 DK-265 SE-181815 DK-265 SE-1818 DK-265 SE-2015 DK-265 SE-2020 DK-265 SE-2520 DK-265 commonsizes
  • 15. 15 * These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at the surgeon’s discretion. A more accurate selection and placement can be obtained by observing the joint or osteotomy at the time of exposure. 10 Chevron Osteotomy of the Distal Fifth Metatarsal/Bunionette Excision Expose the dorsolateral aspect of the distal fifth metatarsal. Excise the osseous bunion. Create a distal transverse osteotomy and resect appropriate bone to achieve the desired deformity correction. Displace the distal fifth metatarsal head medially if desired. Hold the osteotomy reduction manually or with a temporary K-wire. Remove osteophytes or bony prominences with a rongeur to slightly recess the implant. Measure for the implant bridge width using the Implant Sizing Guide (SG-1). Ensure that each prong is at least 3-4mm from the osteotomy line. Ideally, the osteotomy line should bisect the distance between the prongs of the Sizing Guide. 8 Open the chosen Implant Kit and its corresponding Drill Bit Kit. 9 Attach the Drill Guide Tip (found in the Implant Kit) to the Drill Guide Handle (found in the Drill Bit Kit). 10 While ensuring full reduction, align the drill guide across the osteotomy. Ensure both prongs of the Drill Guide are touching bone. 11 Drill the first hole using the supplied Drill Bit (found in the Drill Bit Kit). The Drill Guide contains a positive stop that corresponds to the length of the legs of the chosen implant (or the longest leg of an asymmetric implant). 7 6 5 3 4 2 Indications: • Bunionette deformity • High IV-V intermetatarsal angle. Fixation is achieved with one implant placed in the lateral or dorsolateral position. 1 12 Insert a Locator Pin (found in the Drill Bit Kit) into the first hole. 13 While ensuring full reduction, drill the second hole. Insert a Locator Pin into the second hole, if desired. 14 Remove the Drill Guide. Locator Pin(s) may be left in place to facilitate finding the drill holes. 15 Insert the Speed implant into the drill holes until the storage/insertion stick is fully seated against bone. Fluoroscopy may be used at this point to verify placement. 16 Twist the stick in either direction to disengage it from the implant and apply immediate compression. 17 Use the Tamp (found in the Drill Bit Kit) to fully seat the implant. 18 Close using established surgical techniques. Speed™ Implant Kit Corresponding Drill Bit Kit SE-0907 DK-200 SE-0910 DK-200 SE-1110 DK-200 commonsizes
  • 16. BioMedical Enterprises, Inc. 14785 Omicron Dr., Ste. 205 • San Antonio, Texas 78245 Phone: (210) 677-0354 • Fax: (866) 913-3977 Customer Service: (800) 880-6528 www.bme-tx.com • email: sales@bme-tx.com FDA Cleared. CE Marked. Patents Pending.A120-014 (Rev 1) 0434 ©2012 BioMedical Enterprises, Inc. All rights reserved. Speed is a trademark of BioMedical Enterprises, Inc. madeinusa