# Arthrex, Inc.

- Location (FDA's records): Naples, FL
- FDA decisions: 355 (1992–2026): 355 510(k) clearances
- Product codes: MBI (52), HWC (47), MAI (46), HRS (39), HRX (27), GAT (19), HTN (16), KWS (15), HTY (13), PHX (11), GCJ (9), JDR (6)
- 510(k) review time since 2016: median 90 days, against 94 for FDA's reviews in the same codes and years (87 of 165 faster)
- Predicates its devices cite: 603 (408 its own); citations of its devices by later devices: 905 (408 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 18 (https://510kreport.com/company/synthes-usa)
- Smith & Nephew, Inc.: 16 (https://510kreport.com/company/smith-nephew)
- Advanced Orthopaedic Solutions, Inc.: 12 (https://510kreport.com/company/advanced-orthopaedic-solutions)
- Accelerated Innovation, LLC: 10 (https://510kreport.com/company/accelerated-innovation)
- Wrightmedicaltechnologyinc: 9 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Zimmer, Inc.: 6 (https://510kreport.com/company/zimmer)
- Accin Corporation: 6 (https://510kreport.com/company/accin)
- Biomet Manufacturing Corp: 5 (https://510kreport.com/company/biomet-manufacturing)

## Firms that cite its devices most
- Medos International SARL: 27 (https://510kreport.com/company/medos-international)
- Stryker Endoscopy: 20 (https://510kreport.com/company/stryker-endoscopy)
- GM Dos Reis Industria e Comercio Ltda.: 16 (https://510kreport.com/company/gm-dos-reis-industria-e-comercio)
- Depuy Mitek, A Johnson & Johnson Company: 15 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Responsive Arthroscopy, LLC: 11 (https://510kreport.com/company/responsive-arthroscopy)
- Mtp Solutions, LLC: 10 (https://510kreport.com/company/mtp-solutions)
- Bionx Implants, Inc.: 10 (https://510kreport.com/company/bionx-implants)
- Smith & Nephew, Inc.: 10 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family (2006), cited by 34
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), cited by 26
- K103705: Low Profile Screws (2011), cited by 22
- K101679: Arthrex Pushlock Anchors (2010), cited by 21
- K063479: Arthrex Pushlock (2006), cited by 17
- K050259: Arthrex Bio-Pin (2005), cited by 16

## Recent decisions
- K262975: Arthrex Beaming System (Sep 25, 2026)
- K262618: Arthrex Spine Compression FT Screw (Sep 24, 2026)
- K262451: Arthrex DynaNite Staples (Sep 1, 2026)
- K262357: Arthrex Bioabsorbable PushLock Suture Anchors (Aug 7, 2026)
- K260624: Arthrex Radial Head Replacement System (Jul 30, 2026)
- K260018: Arthrex FiberButton (Jun 26, 2026)
- K260809: Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (Jun 25, 2026)
- K253931: Arthrex Bioabsorbable PushLock Suture Anchors (May 28, 2026)

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