# Zimmer, Inc.

- Location (FDA's records): Warsaw, IN
- FDA decisions: 426 (1976–2026): 423 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Zimmer, Inc. (380); Zimmer GmbH (43); Zimmer (3)
- Product codes: JWH (51), LPH (46), LZO (34), HRS (32), JDI (27), HSB (23), MBH (19), HWC (12), PHX (10), KTT (10), KWA (9), HSX (9)
- 510(k) review time since 2016: median 96 days, against 113 for FDA's reviews in the same codes and years (37 of 70 faster)
- Predicates its devices cite: 757 (470 its own); citations of its devices by later devices: 936 (470 its own)
- Recalls linked to its devices: 795 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sulzer Orthopedics, Inc.: 30 (https://510kreport.com/company/sulzer-orthopedics)
- Synthes (Usa): 29 (https://510kreport.com/company/synthes-usa)
- Biomet, Inc.: 29 (https://510kreport.com/company/biomet)
- Biomet Manufacturing Corp: 22 (https://510kreport.com/company/biomet-manufacturing)
- Depuy, Inc.: 13 (https://510kreport.com/company/depuy)
- Intermedics Orthopedics: 12 (https://510kreport.com/company/intermedics-orthopedics)
- DePuy Orthopaedics, Inc.: 10 (https://510kreport.com/company/depuy-orthopaedics)
- Pioneer Surgical Technology: 10 (https://510kreport.com/company/pioneer-surgical-technology)

## Firms that cite its devices most
- Medacta International S.A.: 31 (https://510kreport.com/company/medacta-international)
- Lima Corporate S.P.A.: 19 (https://510kreport.com/company/lima-corporate)
- United Orthopedic Corporation: 17 (https://510kreport.com/company/united-orthopedic)
- Smith & Nephew, Inc.: 15 (https://510kreport.com/company/smith-nephew)
- Normed Medizin-Technik GmbH: 15 (https://510kreport.com/company/normed-medizin-technik)
- Biomet, Inc.: 15 (https://510kreport.com/company/biomet)
- Tornier, Inc.: 13 (https://510kreport.com/company/tornier)
- Zimmer Switzerland Manufacturing GmbH: 13 (https://510kreport.com/company/zimmer-switzerland-manufacturing)

## Its most-cited devices
- K033363: Zimmer Unicompartmental Knee System (2004), cited by 22
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO (1999), cited by 19
- K792022: Herbert Bone Screw (1979), cited by 18
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System (2009), cited by 18
- K113369: Zimmer Persona Knee System (2012), cited by 17
- K071535: Biolox Delta Ceramic Femoral Head (2007), cited by 15

## Recent decisions
- K262955: OsseoFit Stemless Shoulder System (Sep 24, 2026)
- K261683: Augment Off-Axis Instrument System (Jun 16, 2026)
- K260831: Z1 Hip System (Jun 16, 2026)
- K251840: Zimmer® Persona® Personalized Knee System (May 28, 2026)
- K260182: Avenir® Müller Stem; Avenir Complete™ Hip System (Apr 27, 2026)
- K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (Apr 13, 2026)
- K253566: Affixus Retrograde Femoral Nailing System (Mar 12, 2026)
- K253189: Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (Mar 9, 2026)

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