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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 surg...
3
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surg...
4
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surg...
5
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surg...
6
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surg...
7
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surg...
8
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surg...
9
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the surg...
10
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the sur...
11
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the sur...
12
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the sur...
13
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the sur...
14
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the sur...
15
*	These sizes and styles are consistent with the protocol suggested by BME. Ultimately, implant selection is at
the sur...
BioMedical Enterprises, Inc.
14785 Omicron Dr., Ste. 205 • San Antonio, Texas 78245
Phone: (210) 677-0354 • Fax: (866) 913...
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A staple

  1. 1. Technique Manual Foot&Ankle Procedures theworld’sfirstandonly disposablecompressive fixationsystem* *patents pending
  2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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