Foot Product Portfolio

Transcription

1 Foot Product Portfolio

2 PUT YOUR BEST FOOT FORWARD With Our Best in Class Forefoot Products Toe DF HemiCAP First-Metatarsal Hemi-Arthroplasty ToeMotion Total Toe Implant System AlignMate Lapidus Procedure Toe HemiCAP Lesser Metatarsal Hemi-Arthroplasty CheckMATE Fusion Plate System ToeMATE Hammertoe Correction System OsteoMATE Fusion Allograft KISSloc Hallux Valgus Correction System

3 Implant Systems HemiCAP Toe -Lesser Met HemiCAP Toe DF ToeMotion Total Toe BaseCAP

4 Features & Benefits The Toe HemiCAP Systems Inlay arthroplasty provides stability and preserves bone Dual curves allow for dorsal roll off and dorsal flange prevents osteophytes Double rock solid fixation with morse taper interlock Multiple sizes & curvatures Poly inserts available with multiple offsets & thicknesses Easy & accurate instrumentation 1.5mm offset 3.6mm 4.6mm 2.5mm offset 3.6mm 4.6mm

5 LESSER METATARSAL SURFACE RESTORATION without compromise Specifically designed for the lesser metatarsals Proven fixation provides a stable implant Minimal bone removal maintains future options Anatomic Inlay maintains the length of the 2nd metatarsal This newer resurfacing technique has allowed rapid recovery and dramatic improvement in pain and function in advanced cases where a joint destructive procedure will be necessary. Lesser Metatarsal Head Resurfacing Procedure for Freiberg s Infraction. Goecker, RM. McGlamry s Comprehensive Textbook of Foot and Ankle Surgery, Chapter 2, 2012

6 PROVEN RESULTS The HemiCAP DF has rock solid fixation, a unique metatarsal based design and a proven clinical history with over 30,000 MTP implants. Radiographic evaluation of the HemiCAP prosthesis in 56 patients demonstrated no significant evidence of loosening; it appeared to show superior radiographic results compared to those of other metallic implants using a stemmed design. Thomas San Giovanni, MD; Arthrosurface HemiCAP Resurfacing. Chapter 21. Operative Techniques in Orthopaedic Surgery, 2010

7 The ToeMotion Modular Restoration System restores mobility and maintains native biomechanics using a dual curved HemiCAP DF and a modular tray-style phalangeal implant with a threaded baseplate. Fourth generation fixation components provide stable constructs on both sides of the joint.

8 ROCK SOLID FIXATION Designed to address the primary failure mode of MTP implants-loosening. Bead blasted MTP screw surface provides superior fixation Morse Taper interlocks the two components Screw based fixation provides a stable implant on both sides of the joint UNIQUE DESIGN 1.5mm offset 2.5mm offset 3.6mm 4.6mm 3.6mm 4.6mm Engineered to reproduce the unique kinematics of the MTP joint. Poly inserts available with multiple offsets & thicknesses Standardized thread pitch for precise depth adjustment Dual MTP implant curvatures improves dorsal roll-off ARTICULATION. FIXATION. PRESERVATION.

9 WHAT FUSION?

10 PATIENT GUIDE FOR THE TREATMENT OF TOE ARTHRITIS A NATIONWIDE SURGEON SURVEY ON OVER 2,000 HEMICAP TOE PROCEDURES Surgeons Choice 97% Overall Satisfaction 98% of surgeons indicated that they would undergo a Toe HemiCAP Arthroplasty themselves and would recommend the procedure to their friends and family. of surgeons surveyed reported Very Good to Excellent Satisfaction ratings with the Toe HemiCAP & ToeMotion Implant systems. SATISFACTION WITH RETURN TO DAILY ACTIVITIES 49% 43% 8% 0% 0% 8% 43% 49% Excellent Very Good Good Fair Poor SATISFACTION WITH RETURN TO WORK 33% 37% 67% 57% 57% 37% 6% 0% 0% Excellent Very Good Good Fair Poor SATISFACTION WITH RETURN TO SPORT/ LIFESTYLE 6% 14% 46% 40% 46% 14% 0% 0% 40% Excellent Very Good Good Fair Poor

11 Typical Timepoints for the Resumption of Activity After Toe HemiCAP or ToeMotion Total Toe Surgery (Weeks)

12 A MATCH MADE IN MOTION Phalangeal Hemiarthroplasty The BaseCAP Hemiarthroplasty System uses proven fixation technology with surface mapping to recreate a congruent articulation. The Only Phalangeal Implant that matches the anatomic curvature of the metatarsal head Universal Instrumentation for ease of use

13 ANATOMIC DESIGN (1) Engineered to match the anatomic curve of the metatarsal head (2) Super smooth modular implants available in 4 curvatures (3) Minimal bone resection and implant stability preserves joint anatomy UNIVERSAL INSTRUMENTATION One instrument tray for 3 different implant systems Simple instrumentation for quick installation References native anatomy to optimize implant fit 90 PROVEN TECHNOLOGY RESULTS 10 years of MTP clinical history Over 30,000 MTP implants performed No published implant dissociation or subsidence

14 MTP Arthrodesis System When it s your last move...

15 CheckMATE 1.0 Plate 1.7 mm Thick 50 mm Long 11 mm Wide 4 Locking Holes 2 Non-Locking Holes 1 Compression Slot CheckMATE 2.0 Plate 1.7mm Thick 55mm Long 15mm Wide 6 Variable Angle Locking Holes 1 Compression Slot CheckMATE 3.0 Plate 1.7mm Thick 45mm Long 14-15mm Wide 6 Variable Angle Locking Holes 1 Compression Slot

16 Locking Bone Screws: Ø3.0 mm; L: 8 mm to 24 mm Bailout Screws: Ø3.5 mm; L: 14 mm, 16mm,18 mm Non-Locking Bone Screws: Ø3.0 mm; L: 8 mm to 24 mm Interfragmentary Bone Screws: Ø3.5 mm; L: 18 mm to 30 mm

17 With the CheckMATE plate you also get built in Surgical Speed Elements Custom low profile elevator to gain exposure of metatarsal head & phalangeal base. Includes built in templates for sizing purposes. Plates are provided sterile, in Right & Left Configurations with lengths from 45mm to 55mm. Metatarsal and Phalangeal Reamers designed to prevent over-reaming and shortenting of bones 3.0mm and 3.5mm bailout screws are available in lengths ranging from 8mm to 24mm. Tack pins provide temporary fixation to stabilize bone plate over the MTP Joint Multiple plate options with either a combination of locking and non-locking holes or all-locking variable angle holes for primary or revision cases. Compression clamp technology built into the plate allows up to 3mm compression across the MTP joint. Variable angle locking holes allow desired orientation of screw placement.

18 SIMPLE. Suture System STRONG. FAST. A factor in second metatarsal protection is plate size. A plate with a larger footprint will disperse a load over a larger area, reducing the bone stress. The KISSloc Plate has approximately 3x the footprint of the Mini TightRope Suture Button. KISSloc (Arthrosurface ) Other Devices Mini TightRope Single hole plate showing non-uniform load dispersion with high strain points KISSloc Double hole plate showing uniform load dispersion with evenly distributed strain points

19 The KISSloc Suture System consists of two low profile titanium plates and a self-cinching suture construct. The system corrects Hallux Valgus by reducing the intramedullary angle between the 1 st and 2 nd metatarsal bones. KISSloc allows accurate tunnel placement, uses strong #5 suture, and the self-cinching feature adjusts the correction angle for each patient individually. The small Ø1.2 mm bone tunnels and low profile plates minimize stress risers and distributes the load across each bone bridge. Stability & flexibility without stiffness: KISSloc can be placed proximally or distally and locks motion in the coronal plane while still allowing sagittal motion. Artifact-free titanium plates allow for better post-op imaging. Construct Slip (mm) vs. Cycles Tested KISSloc (Arthrosurface ) Mini TightRope (Arthrex) 6.07 mm 3.53 mm 42% Less Construct Slippage 0 Cycles 100 Cycles 200 Cycles 300 Cycles 400 Cycles Dynamic ramp test data on file at Arthrosurface Inc.

20 A STRONG Step in the Right Direction Hammertoe Implant Post-Op X-ray ToeMATE is an easy to implant bone screw system intended for the correction of hammertoe deformity. It is provided in a complete packaged and sterile kit.

21 1 Implant components completely embedded in the phalangeal bones i.e. no implant exposure postop avoids complications associated with pin tract infection. 4 All instruments hand driven. No power tools or connection required. *Except for xsmall 2 Available in 3 Sizes: Large - Ø 4.7mm Small - Ø 3.8mm X-Small - Ø 3.2mm 5 Easy to separate and remove implant components in case of revisions. * Implants not shown to scale 3 Tapered screw design & morse taper lock provide maximum grip & strong construct fixation. 6 All implants and instruments provided in a complete packaged & sterile kit. This eliminates missing instruments, incomplete trays and minimizes the risk of infection. PROVEN, STRONG & STABLE FIXATION QUICK & ACCURATE JOINT ALIGNMENT SMALL & LARGE TAPERED SCREWS WITH CONICAL DESIGN STRAIGHT & 10 o PLANTAR FLEXED IMPLANT OPTIONS

22 #STAYACTIVE Provide Stability with the AlignMate Lapidus System Now, you no longer need to sacrifice patient comfort for strength with the AlignMate Lapidus Arthrodesis System. A strong, thin, titanium plate which conforms to your patients anatomy and provides the strength needed during the healing period. Features & Benefits: 1.0mm low profile plate design conforms to anatomy Titanium material provides strength during the healing period Plates are pre-contoured to be Left, Right specific Large & Small plates to accomodate patient size Will accept both locking and non-locking screws Compression slot which accepts tack pin, allowing use of compression pliers Thin Strong Secure

23 STRONG, THIN & SECURE PLATES 9B00-100L Bone Plate, Left 39mm Interfragmentary Guide easily fits over tack pin, provides management of IF Screw trajectory for consistant screw placement. Compression Clamp provides manual compression prior to screw fixation - eliminates bone surface separation during screw insertion 9B00-100R Bone Plate, Right, 39mm 9B00-200L Bone Plate, Left 34mm 9B00-200R Bone Plate, Right 34mm INTERFRAGMENTARY SCREWS 9B dia 4.0mm x 36mm 9B dia 4.0mm x 38mm 9B dia 4.0mm x 40mm 9B dia 4.0mm x 42mm 9B dia 4.0mm x 44mm 9B dia 4.0mm x 46mm 9B dia 4.0mm x 48mm 9B dia 4.0mm x 50mm INSTRUMENTS 9B Pin Kit, AlignMATE 9B Driver Kit, AlignMATE Plates are provided sterile, in Right & Left Configurations and are used with the CheckMATE Arhrodesis System Instrumentation PN REV E

24 TM Allograft Fusion System INCORPORATE BONE INTO YOUR LISFRANC ARTHRODESIS The First Arthrodesis System Comprised of Allograft Bone The OsteoMATE Allograft Fusion System utilizes a pre-shaped/pre-drilled implant harvested from dense cortical bone. The rounded edge radiolucent allograft bone implant design provides; 360-degree bone against bone transition area to facilitate bony incorporation Visualization of fusion area under x-ray A streamlined implant fit which addresses concerns related to impingement Cortical allograft stiffness provides strength of the implant and may result in less micromotion 20 PEEK Implant vs. OsteoMATE Construct Rigidity Construct Rigidity (N/mm) PEEK OsteoMATE

25 CREATE AN ANATOMIC FUSION COMPLEX OF ALLOGRAFT AND NATIVE BONE ALLOGRAFT BONE FUSION COMPLEX - when using the OsteoMATE Allograft implant, screw forces are transmitted over like materials; allograft and native bone, which have a consistent modulus. Consistency in modulus results in a more streamlined force transmission within a fusion complex. This minimal force transmission change can lead to a more stable fixation. Divergent angled pre-drilled screw holes facilitates dynamic compression of the bones being fused. 20mm Implant 16 & 20mm Implants 4.7mm thick EASE OF USE Disposable instruments are ready when you are, facilitating quick room turnover. A dedicated, specialized reamer allows visual confirmation of reaming depth, with a resultant reamed geometry matched to the allograft implant. The proprietary Screw Guide allow visual confirmation of screw placement into each bone prior to final implant placement.

26 A-Curve * The overriding finding of the present study is that small subchondral drill holes reflecting the physiological subchondral trabecular distance significantly improve osteochondral repair. Eldracher M, et. al. Small subchondral drill holes improve marrow stimulation of articular cartilage defects. AJSM 2014 Nov;42(11): Specially designed curve for hard to access ankle lesions Reduces surface skyving for off-axis channel preparation Improves bone marrow access for cartilage repair procedures Thumble Handle Instrument

27 * Significant enhancements were observed at the level of individual parameters and of overall histological articular cartilage repair, together with improved immunoreactivity to type II and type I collagen of the cartilaginous repair tissue. Second, the microarchitecture of both the subchondral bone plate and the subarticular spongiosa was better reconstituted. Eldracher M, Orth P, Cucchiarini M, Pape D, Madry H. Small subchondral drill holes improve marrow stimulation of articular cartilage defects. Am J Sports Med Nov;42(11): mm Channels Microfracture 1mm Channels NanoFx Step 1: Assemble & Orient on Lesion Step 2: Gently tap to depth stop Step 3: Push thumble to extract pluristik. Repeat. Figures: open trabecular channels; closed trabecular channels, microct comparison: Axial (top), Sagittal (bottom). Microfracture 1mm K-Wire Nanofracture

28 This product is covered by one or more of U.S. Patent Nos. 6,520,964; 6,610,067; 6,679,917 and other patents pending. HemiCAP is a trademark of Arthrosurface, Inc. U.S Arthrosurface, Inc. All rights reserved. Printed in U.S.A. For more information, visit our website: 28 Forge Parkway Franklin, MA fax: This pamphlet and information is intended for markets where regulatory approval has been granted. PN REV B