# Arthrosurface, Inc.

- Location (FDA's records): Franklin, MA
- FDA decisions: 26 (2004–2021): 26 510(k) clearances
- Product codes: KWD (5), HWC (4), HRS (4), KRR (3), HTN (2), HSD (2), KWN (1), PHX (1), HSX (1), KWS (1), JWJ (1), LZJ (1)
- 510(k) review time since 2016: median 107 days, against 127 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 66 (18 its own); citations of its devices by later devices: 41 (18 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 9 (https://510kreport.com/company/arthrex)
- Wrightmedicaltechnologyinc: 4 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Biomet Manufacturing Corp: 4 (https://510kreport.com/company/biomet-manufacturing)
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Nextremity Solutions, Inc.: 1 (https://510kreport.com/company/nextremity-solutions)

## Firms that cite its devices most
- Vilex IN Tennessee, Inc.: 3 (https://510kreport.com/company/vilex-in-tennessee)
- Osteomed LP: 2 (https://510kreport.com/company/osteomed)
- Biomet Manufacturing Corp: 2 (https://510kreport.com/company/biomet-manufacturing)
- Overture Resurfacing, Inc.: 2 (https://510kreport.com/company/overture-resurfacing)
- Synchro Medical: 1 (https://510kreport.com/company/synchro-medical)
- Catalyst Orthoscience, Inc.: 1 (https://510kreport.com/company/catalyst-orthoscience)
- Vilex, LLC: 1 (https://510kreport.com/company/vilex)
- Retrofix Screws, LLC: 1 (https://510kreport.com/company/retrofix-screws)

## Its most-cited devices
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant (2004), cited by 9
- K130859: Hammertoe Correction System (2013), cited by 4
- K060127: Hemicap Patello-Femoral Resurfacing Prosthesis (2006), cited by 4
- K091196: GRS Glenoid Resurfacing System (2009), cited by 3
- K131377: Hemicap MTP Resurfacing Hemi-Arthroplasty Implant (2013), cited by 3
- K071413: Hemicap Patello-Femoral Resurfacing System (2007), cited by 2

## Recent decisions
- K203375: OVOMotion Reverse Shoulder Arthroplasty System (Jun 24, 2021)
- K200718: Arthrosurface WristMotion Total Wrist Arthroplasty System (Oct 15, 2020)
- K190261: BOSS Toe Fixation System (Aug 14, 2019)
- K181280: Patello-Femoral Wave (Kahuna) Arthroplasty System (Jun 14, 2018)
- K173964: OVOMotion Shoulder Arthroplasty System (Apr 18, 2018)
- K172383: Arthrosurface Bone Screws (Dec 22, 2017)
- K170440: KISSloc Suture System (May 3, 2017)
- K170350: ToeMATE® Hammertoe Correction System (Mar 3, 2017)

Source page: https://510kreport.com/company/arthrosurface