# Medacta International S.A.

- Location (FDA's records): Castel San Pietro (Ch), CH
- FDA decisions: 208 (2008–2026): 208 510(k) clearances
- Names in FDA's records: Medacta International S.A. (167); Medacta International (39); Medacta International, SA (1); Medacta International SA (1)
- Product codes: LZO (38), JWH (28), MBI (15), PHX (13), NKB (12), LPH (11), SBF (10), MAX (8), OVD (7), NKG (6), LLZ (5), HSX (5)
- 510(k) review time since 2016: median 96 days, against 111 for FDA's reviews in the same codes and years (66 of 143 faster)
- Predicates its devices cite: 713 (405 its own); citations of its devices by later devices: 453 (405 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zimmer, Inc.: 31 (https://510kreport.com/company/zimmer)
- Synthes Spine: 18 (https://510kreport.com/company/synthes-spine)
- Smith & Nephew, Inc.: 18 (https://510kreport.com/company/smith-nephew)
- Depuy Spine, Inc.: 15 (https://510kreport.com/company/depuy-spine)
- DePuy Orthopaedics, Inc.: 13 (https://510kreport.com/company/depuy-orthopaedics)
- Medtronic Sofamor Danek: 12 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes (Usa): 10 (https://510kreport.com/company/synthes-usa)
- Medacta Inernational SA: 10 (https://510kreport.com/company/medacta-inernational)

## Firms that cite its devices most
- Medacta Inernational SA: 6 (https://510kreport.com/company/medacta-inernational)
- Implantcast GmbH: 5 (https://510kreport.com/company/implantcast)
- Alphatec Spine, Inc.: 2 (https://510kreport.com/company/alphatec-spine)
- Corentec Co., Ltd.: 2 (https://510kreport.com/company/corentec)
- Astura Medical: 2 (https://510kreport.com/company/astura-medical)
- Xerxes Arthopedix, LLC: 2 (https://510kreport.com/company/xerxes-arthopedix)
- Aesculap Implant System, Inc.: 2 (https://510kreport.com/company/aesculap-implant-system)
- Mighty Oak Medical, Inc.: 1 (https://510kreport.com/company/mighty-oak-medical)

## Its most-cited devices
- K090988: GMK Total Knee System (2009), cited by 18
- K103721: Mpact Acetabular System (2011), cited by 16
- K121115: M.U.S.T Pedicle Screw System (2012), cited by 13
- K121416: GMK Sphere (2012), cited by 12
- K102437: GMK Revision Knee System (2010), cited by 11
- K110927: Mectalif (2011), cited by 9

## Recent decisions
- K260173: M-Vizion Femoral Revision System Extension (Sep 17, 2026)
- K262057: GMK Extension (Sep 15, 2026)
- K253630: Mpact 3D Metal Foam (Aug 28, 2026)
- K261016: MSS - Humeral reverse liners extension (Jun 10, 2026)
- K254202: MectaLIF 3D Metal Anterior (May 5, 2026)
- K253940: M.U.S.T. Pedicle Screw System - Extension (Apr 28, 2026)
- K253328: GMK 3D Metal Tibial Tray Extension (Feb 26, 2026)
- K250644: MSS - Monobloc stem (Feb 3, 2026)

Source page: https://510kreport.com/company/medacta-international