Embed Size (px)
Citation preview
Foot and Ankle Solutions
ArthroplastyArthroereisisSoft Tissue FixationStaple FixationScrew FixationSterile Instruments
The following catalog contains BioPro’s current foot and ankle product offerings.
Contact informationWebsite:www.bioproimplants.com
Email:[email protected]@bioproimplants.com
Phone: (810) 982-7777
Fax: (810) 982-7794
Address: 2929 Lapeer Rd, Port Huron, MI 48060
1
Table of contentsArthroplasty 2-4Arthroereisis 5Soft Tissue Fixation 6Staple Fixation 7Screw Fixation 8-10Sterile Instruments 11-14
Con
tent
s
2
Arthroplasty
The First MPJ Hemi Implant
The First MPJ Hemi Implant is the globally trusted solution for the treatment of hallux rigidus/limitus. In clinical use for over 65 years10, the First MPJ Hemi Implant continues to demonstrate improved motion, long term survivorship and pain relief. 7,10,11
1. Timothy Voskuijl, MD, Ron Onstenk, MD. Operative Treatment for Osteoarthritis of the First Metatarsophalangeal Joint: Arthrodesis Versus Hemiarthroplasty. The Journal of Foot & Ankle Surgery (2015) 1–42. Karin H. Simons, MD, Pieter van der Woude, MD, Frank W.M. Faber, MD, PhD , Paulien M. van Kampen, PhD , Bregje J.W. Thomassen, PhD. Short-Term Clinical Outcome of Hemiarthroplasty Versus Arthrodesis for End-Stage Hallux Rigidus. The
Journal of Foot & Ankle Surgery (2015) 1–43. Giza E, Sullivan MR. First Metatarsophalangeal Hemiarthroplasty for Grade III and IV Hallux Rigidus Techniques in Foot and Ankle Surgery 4(1):10-17,20054. Clement, N. D., MacDonald, D., Dall, G. F., Ahmed, I., Duckworth, A. D., Shalaby, H. S., & McKinley, J. (2016). Metallic hemiarthroplasty for the treatment of end-stage hallux rigidus. Bone Joint J, 98-B(7), 945-951.5. Taranow, DO. et al. Contemporary Approaches to Stage II and III Hallux Rigidus: The Role of Metallic Hemiarthroplasty of the Proximal Phalanx. Foot and Ankle Clinics , Volume 10 , Issue 4 , 713 - 7286. Roukis TS, Townley, MD. BIOPRO resurfacing endoprosthesis versus periarticular osteotomy for hallux rigidus: short-term follow-up and analysis. Journal of Foot & Ankle Surgery 2003;42(6):350-87. Juan C. Goez, DPM, Charles O. Townley MD, Warren Taranow, DO. An Update on the Metallic Hemiarthroplasty Resurfacing Prosthesis for the Hallux. Presented at the 56th Annual Meeting and Scientific Seminar of the American College of Foot
and Ankle Surgeons. Orlando FL February 19988. Charles G. Kissel, DPM, FACFAS, Zeeshan S. Husain, DPM AACFAS, Paul H. Wooley, PhD, Michael Kruger, MS, Mark A. Schumaker, DPM, Michael Sullivan, DPM, and Todd Snoeyink, DPM. A Prospective Investigation of the Biopro® Hemi-Ar-
throplasty for the First Metatarsophalangeal Joint. The Journal of Foot & Ankle Surgery 47(6):505–509, 20089. Taranow, DO , Townley, MD. Metallic proximal phalangeal hemiarthroplasty for hallux rigidus. Operative Techniques in Orthopaedics 1999;9(1):3310. Townley, MD, Taranow, DO. A metallic hemiarthroplasty resurfacing prosthesis for the hallux metatarsophalangeal joint. Foot & Ankle International 1994;15(11):575-8011. Christine C. Salonga, DPM, David C. Novicki, DPM, FACFAS , Martin M. Pressman, DPM, FACFAS , D. Scot Malay, DPM, MSCE, FACFAS. A Retrospective Cohort Study of the BioPro Hemiarthroplasty Prosthesis. The Journal of Foot & Ankle
Surgery 49 (2010) 331–33912. Giza, E., Sullivan, M., Ocel, D., Lundeen, G., Mitchell, M., & Frizzell, L. (2010). First metatarsophalangeal hemiarthroplasty for hallux rigidus. International Orthopaedics, 34(8), 1193–1198. http://doi.org/10.1007/s00264-010-1012-x
Advantages
• Supporting clinical studies 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
• 20+ year implant survivorship7,10
• Demonstrated an average of 55% improved dorsiflexion11
• 95%+ implant survivorship2,3,7,10
• Titanium option available for patients with metal sensitivities
ITEM # DESCRIPTION SIZE10412 COBALT CHROME POROUS COATED 17MM17034 COBALT CHROME POROUS COATED 18.5MM10413 COBALT CHROME POROUS COATED 20MM14960 COBALT CHROME POROUS COATED 21.5MM10414 COBALT CHROME POROUS COATED 23MM10060 COBALT CHROME NON-POROUS COATED 17MM17033 COBALT CHROME NON-POROUS COATED 18.5MM10061 COBALT CHROME NON-POROUS COATED 20MM14958 COBALT CHROME NON-POROUS COATED 21.5MM10062 COBALT CHROME NON-POROUS COATED 23MM17035 TITANIUM POROUS COATED 17MM17197 TITANIUM POROUS COATED 18.5MM17036 TITANIUM POROUS COATED 20MM17037 TITANIUM POROUS COATED 21.5MM17038 TITANIUM POROUS COATED 23MM16813 TITANIUM NON-POROUS COATED 17MM17198 TITANIUM NON-POROUS COATED 18.5MM16814 TITANIUM NON-POROUS COATED 20MM16815 TITANIUM NON-POROUS COATED 21.5MM16816 TITANIUM NON-POROUS COATED 23MM
3
HemiEDGE™
Based on the clinical success of our First MPJ Hemi Implant, the HemiEDGE™ incorporates an overlapping edge extending around the medial, lateral and dorsal aspects of the implant. Partially encompassing the cortex of the phalanx helps ensure proper implant sizing, improve implant stability, and reduce the potential of bony overgrowth.
ITEM # DESCRIPTION SIZE19538 HEMI EDGE IMPLANT NPC 17MM19539 HEMI EDGE IMPLANT NPC 18.5MM19540 HEMI EDGE IMPLANT NPC 20MM19541 HEMI EDGE IMPLANT NPC 21.5MM19542 HEMI EDGE IMPLANT NPC 23MM
Art
hrop
last
y
Advantages
• Reduce the potential of bony overgrowth• Improve implant stability1
• Visualization portals ensure proper implant-to-bone seating• Facilitate consistent placement and orientation
1. Jerome A. Slavitt, DPM, FACFAS. A Closer Look At A First MPJ Hemi-Implant For The Treatment Of Hallux Limitus/Rigidus. Podiatry Today Volume 30 - Issue 2 - February (2017)
The Lesser MPJ Hemi Implant
The Lesser MPJ Hemi Implant is proven to provide significant restoration of joint function and pain relief.
ITEM # DESCRIPTION SIZE16818 LESSER MPJ HEMI 8.00MM16867 LESSER MPJ HEMI 8.75MM16819 LESSER MPJ HEMI 9.50MM16820 LESSER MPJ HEMI 10.25MM16821 LESSER MPJ HEMI 11.00MM16822 LESSER MPJ HEMI 11.75MM16868 LESSER MPJ HEMI 12.50MM16869 LESSER MPJ HEMI 13.25MM16870 LESSER MPJ HEMI 14.00MM
17324 LESSER MPJ HEMI CANNULATED 8.00MM17325 LESSER MPJ HEMI CANNULATED 8.75MM17326 LESSER MPJ HEMI CANNULATED 9.50MM17327 LESSER MPJ HEMI CANNULATED 10.25MM17328 LESSER MPJ HEMI CANNULATED 11.00MM17329 LESSER MPJ HEMI CANNULATED 11.75MM17330 LESSER MPJ HEMI CANNULATED 12.50MM17331 LESSER MPJ HEMI CANNULATED 13.25MM17332 LESSER MPJ HEMI CANNULATED 14.00MM
Advantages
• Simple surgical procedure1
• Restoration of joint function1,2
• Pain relief1,2
• Minimize the risk of transfer lesions1
• Allow for subsequent procedure options1
1. Alan T. Shih, DPM, Richard E. Quint, DPM, David G. Armstrong, DPM, Brent P. Nixon, DPM. Treatment of Freiberg’s infraction with the titanium hemi-implant. J Am Podiatr Med Assoc. 2004 Nov-Dec;94(6):590-3.
2. Robin L. Pastore, DPM, FACFAS. CASE REPORT - FREIBERG’S. [unpublished raw data]
Arthroplasty
4
Cannulated designs can be utilized in conjunction with an interphalangeal
joint fusion to temporarily stabilize the entire digit.
Art
hroe
reis
isHorizon Subtalar
The Horizon Subtalar incorporates a smooth, slightly tapered lateral trailing edge; assuring that the talus makes contact with a smooth, flat surface when the foot is pronated, not a sharp thread.
ITEM # DESCRIPTION SIZE17478 HORIZON SUBTALAR 6MM17221 HORIZON SUBTALAR 8MM 17222 HORIZON SUBTALAR 9MM 17223 HORIZON SUBTALAR 10MM 17224 HORIZON SUBTALAR 11MM 17225 HORIZON SUBTALAR 12MM 17085 HORIZON HYBRID SUBTALAR 8MM 17086 HORIZON HYBRID SUBTALAR 9MM 17087 HORIZON HYBRID SUBTALAR 10MM 17088 HORIZON HYBRID SUBTALAR 11MM 17089 HORIZON HYBRID SUBTALAR 12MM
Advantages
• A smooth lateral surface ensures both the talus and calcaneus interface with a smooth surface during pronation.
• The slight taper on the smooth lateral surface stabilizes the implant during pronation and protects against lateral migration.
• Cannulated to allow easy insertion over a guide wire.
A hybrid design incorporates a polyethylene sleeve over the lateral portion of the implant, offering a softer, more forgiving surface to
interface with the talus and calcaneus.
5
Tendon Anchor System
The Tendon Anchor System (TAS) is a toothed, titanium anchor designed for soft tissue reattachment to bone. The system provides far greater surface compression than is possible with traditional suture anchor techniques, allowing for earlier patient ambulation†, while reducing OR time. 26MM TAS
10MM TAS
Item # Description Size20070 One Hole Tendon Anchor System 10mm20159 Two Hole Tendon Anchor System 26mm
Advantages
• 183% stronger than suture anchors1
• Up to 30 days earlier patient ambulation2
• Improved procedure efficiency3
1. Jill S. Kawalec-Carroll, PhD. Ohio College of Podiatric Medicine. (2014). Evaluation of a New Device for the Reattachment of the Achilles Tendon. Unpublished raw data.2. Tendon Transfers. American Orthopaedic Foot & Ankle Society. (2017, May 16). Retrieved from www.aofas.org/footcaremd/treatments/Pages/TendonTransfers.aspx3. Cost Analysis and Surgical Site Infection Rates in Total Knee Arthroplasty Comparing Traditional vs. Single-Use Instrumentation Siegel, Geoffrey W. et al.The Journal of Arthroplasty , Volume 30 , Issue 12 ,
2271 - 2274† DATA ON FILE.
Soft Tissue Fixation
6
7
Bridge Width
Leg Length
Wire Size
1. Jill S. Kawalec-Carroll, PhD. Ohio College of Podiatric Medicine. (2014). Evaluation of a New Device for the Reattachment of the Achilles Tendon. Unpublished raw data.2. Tendon Transfers. American Orthopaedic Foot & Ankle Society. (2017, May 16). Retrieved from www.aofas.org/footcaremd/treatments/Pages/TendonTransfers.aspx3. Cost Analysis and Surgical Site Infection Rates in Total Knee Arthroplasty Comparing Traditional vs. Single-Use Instrumentation Siegel, Geoffrey W. et al.The Journal of Arthroplasty , Volume 30 , Issue 12 ,
2271 - 2274† DATA ON FILE.
Standard LegsBridge Width Leg Length Wire Size Drill Ø Color Code Item #
7mm 5mm 1.2mm 1.4mm Blue 176377mm 5mm 1.5mm 1.8mm Green 176289mm 7mm 1.2mm 1.4mm Blue 176389mm 7mm 1.5mm 1.8mm Green 1762911mm 8mm 1.5mm 1.8mm Green 1763011mm 10mm 1.5mm 1.8mm Green 1763113mm 10mm 1.5mm 1.8mm Green 1763215mm 12mm 1.5mm 1.8mm Green 1763315mm 12mm 2.0mm 2.4mm Yellow 1762520mm 20mm 2.0mm 2.4mm Yellow 1762720mm 20mm 2.0x3.0mm 3.0mm Purple 1762225mm 22mm 2.0x3.0mm 3.0mm Purple 1762330mm 30mm 2.0x3.0mm 3.0mm Purple 17624
Offset LegsBridge Width Leg Length A Leg Length B Wire Size Drill Ø Color Code Item #
11mm 15mm 13mm 1.5mm 1.8mm Green 1763411mm 17mm 15mm 1.5mm 1.8mm Green 17635
11mm 19mm 17mm 1.5mm 1.8mm Green 1763618mm 18mm 15mm 2.0mm 2.4mm Yellow 17626
Stap
le F
ixat
ionThe Memory Staple
The Memory Staple is a Nitinol device activated at patient body temperature. It features a unique S-bend bridge allowing for even compression across the fusion site while maintaining a low profile against the bone.
Advantages
• 17 standard sizes allow for a wide variety of surgical procedures
• S-bend bridge creates uniform compression• Nitinol allows for continuous compression
8
Screw Fixation
Digital Compression Screw
The Digital Compression Screw is a solid, stainless steel screw specifically designed to address digital fusions. The 1.5mm and 1.8mm diameters range from 20mm to 55mm in length, allowing for fusion of the DIPJ, PIPJ, or both.
Advantages
• The lag design and over-drilling technique allow for compression across the fusion site.
• No exposed wires allow patients to wear a normal, stiff-soled post-operative shoe.
• Once fusion has been achieved, the technique allows for easy in-office screw removal.
• The threads purchase into cortical bone, improving stability and reducing the chance of rotation or residual flexion.
ITEM # DESCRIPTION LENGTH17201 DIGITAL COMPRESSION SCREW 1.5MM 20MM17202 DIGITAL COMPRESSION SCREW 1.5MM 25MM17110 DIGITAL COMPRESSION SCREW 1.5MM 30MM17111 DIGITAL COMPRESSION SCREW 1.5MM 35MM17112 DIGITAL COMPRESSION SCREW 1.5MM 40MM17113 DIGITAL COMPRESSION SCREW 1.5MM 45MM17114 DIGITAL COMPRESSION SCREW 1.5MM 50MM17115 DIGITAL COMPRESSION SCREW 1.5MM 55MM17203 DIGITAL COMPRESSION SCREW 1.8MM 20MM17204 DIGITAL COMPRESSION SCREW 1.8MM 25MM17116 DIGITAL COMPRESSION SCREW 1.8MM 30MM17117 DIGITAL COMPRESSION SCREW 1.8MM 35MM17118 DIGITAL COMPRESSION SCREW 1.8MM 40MM17119 DIGITAL COMPRESSION SCREW 1.8MM 45MM17120 DIGITAL COMPRESSION SCREW 1.8MM 50MM17121 DIGITAL COMPRESSION SCREW 1.8MM 55MM
9
Ø Length IncrementCannulation(K-wire size) Driver Color Feature
2.5mm 10-40mm 2mm 0.035” T-8 Light Blue SDST
3.0mm 10-40mm 2mm 0.035” T-8 Rose Gold SDST
HBS Cannulated Headless Screws
HBS Cannulated Headless Screws are manufactured from implant grade Titanium and available in multiple diameters and lengths. HBS screws are available in Self Drilling/Self Tapping (SDST) or Self Tapping (ST).
Ø Length IncrementCannulation(K-wire size) Driver Color Feature
2.5mm 10-30mm 1mm 0.035” T-8 Purple ST
3.0mm 10-30mm 1mm 0.035” T-8 Gray ST
Scre
w F
ixat
ion
HBS ST SCREWS HBS SDST SCREWSLength (mm)
Ø2.5 (PURPLE)
Ø3.0 (GRAY)
Length (mm)
Ø2.5 (ROSE)
Ø3.0 (BLUE)
10 19545 19566 10 20500 2051611 19546 19567 12 20501 2051712 19547 19568 14 20502 2051813 19548 19569 16 20503 2051914 19549 19570 18 20504 2052015 19550 19571 20 20505 2052116 19551 19572 22 20506 2052217 19552 19573 24 20507 2052318 19553 19574 26 20508 2052419 19554 19575 28 20509 2052520 19555 19576 30 20510 2052621 19556 19577 32 20511 2052722 19557 19578 34 20512 2052823 19558 19579 36 20513 2052924 19559 19580 38 20514 2053025 19560 19581 40 20515 2053126 19561 1958227 19562 1958328 19563 1958429 19564 1958530 19565 19586
10
Ø Length IncrementCannulation(K-wire size) Driver (Hex) Color Feature
2.0mm 6-50mm 2mm 0.035” 1.5mm Blue SDST
2.5mm 6-50mm 2mm 0.035” 1.5mm Purple SDST
3.0mm 6-40mm 2mm 0.045” 2.5mm Green SDST
3.5mm 6-50mm 2mm 0.045” 2.5mm Gold SDST
4.0mm 6-50mm 2mm 0.062” 3.0mm Gray SDST
4.5mm 6-50mm 2mm 0.062” 3.0mm Brown SDST
6.5mm 30-40mm 2mm 2mm 4.0mm Rose Gold SDST
6.5mm 45-120mm 5mm 2mm 4.0mm Rose Gold SDST
The Go-EZ system features three low profile head designs. The Ø2.0/2.5mm have a washer style head, the Ø3.0, 3.5, 4.0, 4.5mm screws have a standard head design and the Ø6.5mm incorporates a rounded head design.
Screw Fixation
Go-EZ Cannulated Headed Screws
Go-EZ Cannulated Headed Screws are manufactured from implant grade Titanium and available in multiple diameters and lengths.
Go-EZ Cannulated ScrewsLength (MM)
Ø2.0 (BLUE)
Ø2.5 (PURPLE)
Ø3.0 (GREEN)
Ø3.5 (GOLD)
Ø4.0 (GRAY)
Ø4.5 (BROWN)
Length (MM)
Ø6.5 (ROSE)
6 18162 18172 18185 18203 18226 18239 30 19651
8 18163 18173 18186 18204 18227 18240 32 1965210 18164 18174 18187 18205 18228 18241 34 1965312 18165 18175 18188 18206 18229 18242 36 1965414 18166 18176 18189 18207 18230 18243 38 1965516 18167 18177 18190 18208 18231 18244 40 1965618 18168 18178 18191 18209 18232 18245 45 1965720 18169 18179 18192 18210 18233 18246 50 1965822 18170 18180 18193 18211 18234 18247 55 1965924 18171 18181 18194 18212 18235 18248 60 1966026 19265 18182 18195 18213 18236 18249 65 1966128 19266 18183 18196 18214 18237 18250 70 1966230 19267 18184 18197 18215 18238 18251 75 1966332 19268 19250 18198 18216 19041 19031 80 1966434 19269 19251 18199 18217 19042 19032 85 1966536 19270 19252 18200 18218 19043 19033 90 1966638 19271 19253 18201 18219 19044 19034 95 1966740 19272 19254 18202 18220 19045 19035 100 1966842 19273 19255 18221 19046 19036 105 1966944 19274 19256 18222 19047 19037 110 1967046 19275 19257 18223 19048 19038 115 1967148 19276 19258 18224 19049 19039 120 1967250 19277 19259 18225 19050 19040
11
Ster
ile In
stru
men
ts
Scarf GuideThe Scarf Guide is a “Z” shaped guide to assist in the popular Scarf procedure. The system includes two guides, a large and a small, with each guide having multiple slots for the dorsal and plantar cuts. This allows for customization of the osteotomy based on the anatomy of the patient’s metatarsal. (ref 19511)
2-Stage GuideThe 2-Stage Guide allows correction of PASA or DMAA, similar to the Reverdin-Gerbert procedure. The system includes a Stage-1 guide for a standard Chevron cut, along with three angled Stage-2 guides allowing 5°, 10°, or 15° of rotation along with lateral transposition. (ref 19509)
DMAA GuideThe DMAA Guide allows for correction of DMAA or PASA with one simple guide. The system includes a Chevron guide with a second dorsal slot, angled at 10°. This allows for lateral transposition plus rotation of the head. (ref 19720)
Chevron (Austin) GuideThe standard Chevron Guide offers a 55° angle for precise cuts on a classic, predictable osteotomy. (ref 19505)
Youngswick GuideThe Youngswick Guide features two dorsal slots, spaced 1mm, 2mm, or 3mm apart. This allows the surgeon to shorten and plantarflex the metatarsal head by 1, 2, or 3 mm, while providing lateral transposition. (ref 19506/19507/19508)
Long-Arm Chevron GuideThe Long-Arm Guide is a 45° chevron with a long dorsal arm. This offers more surface area along the dorsal cut for multiple screw fixation. Additionally, the guide offers three proximal mounting holes, spaced 11° apart, allowing intra-operative adjustment of the cut angle. (ref 19510)
Choose Your Osteotomy.
Accu-Cut Osteotomy Guide System
The Accu-Cut Osteotomy Guide System provides precise and repeatable osteotomies for many types of bunion correction surgery. The guides are provided sterile packed with saw blades and 0.045” K-wires.
ITEM # DESCRIPTION
19505 AUSTIN/CHEVRON GUIDE
19506 YOUNGSWICK 1MM
19507 YOUNGSWICK 2MM
19508 YOUNGSWICK 3MM
19509 2-STAGE PASA/DMAA GUIDE
19510 LONG ARM CHEVRON GUIDE
19511 Z (SCARF) GUIDE
19720 DMAA GUIDE
Sterile Instruments
Effi+Pro®
With over 100mm of movement available, the Effi+Pro allows the surgeon to quickly switch from distraction to compression without changing or repositioning the device. The fine threaded design allows for incremental distraction and compression adjustment, ensuring proper positioning.
Item # Description 20188 EFFI+PRO SINGLE USE KIT
Consider these surgical procedures:
• Talonavicular fusion• Calcaneal-cuboid fusion• Subtalar fusion• Lapidus procedure• Flatfoot reconstruction• Ankle fusion• Ankle scope• Fracture reduction• Opening wedge procedures
12
Fasciotome™
The Fasciotome™ is intended to assist surgeons in percutaneous tenotomies and plantar fasciotomies. The Fasciotome features an extremely sharp, one-sided blade for effortless releases; provided in convenient single-use, sterile packs.
Item # Description 20279 FASCIOTOME SHORT St
erile
Inst
rum
ents
Percutaneous medial fascial release findings.
• 86% good to excellent result with a two-year fol-low-up2
• Minimally invasive option for plantar fascia release1,2
• Faster recovery1
• Less scarring• Can be performed in-office
1. A Retrospective Comparison of Percutaneous Plantar Fasciotomy and Open Plantar Fasciotomy with Heel Spur Resection Fallat, Lawrence M. et al. The Journal of Foot and Ankle Surgery , Volume 52 , Issue 3 , 288 - 290
2. Brian McCurdy. (2013, July). How Effective Is Percutaneous Plantar Fasciotomy? Retrieved from https://www.podiatrytoday.com/july-2013
13
Sterile Instruments
Item # Description 20087 BREAK-OUT SM 2.0-3.5
20088 BREAK-OUT LG 3.0-7.0
Break-Out™
A reverse spiral bit manufactured from stainless steel for easy removal of broken/stripped cannulated screws.
Advantages• Two sizes allow removal of broken or stripped
cannulated screws, ranging from 2.0mm to 7.0mm• Reverse spiral cutting edge securely bites into screw
cannula for easy removal• AO quick connect end allows use in any standard AO
driver or T-handle• Individually sterile packaged
14
15
Notes
Notes
