# Biomet Orthopedics, Inc.

- Location (FDA's records): Warsaw, IN
- FDA decisions: 41 (2000–2026): 41 510(k) clearances
- Names in FDA's records: Biomet Orthopedics, Inc. (35); Biomet Orthopedics (4); Biomet Orthopedics, LLC (1); Biomet Orthopedics Corp. (1)
- Product codes: HSB (4), HWC (4), LPH (4), HRS (4), JDI (3), KWT (3), KRO (2), KXA (2), MQV (2), JWH (2), MEH (2), HRY (1)
- 510(k) review time since 2016: median 258 days, against 112 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 83 (3 its own); citations of its devices by later devices: 81 (3 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
- Biomet, Inc.: 45 (https://510kreport.com/company/biomet)
- Biomet Manufacturing Corp: 6 (https://510kreport.com/company/biomet-manufacturing)
- Synthes (Usa): 5 (https://510kreport.com/company/synthes-usa)
- Wrightmedicaltechnologyinc: 5 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Alphatec Mfg., Inc.: 2 (https://510kreport.com/company/alphatec-mfg)
- Arthrotek, Inc.: 2 (https://510kreport.com/company/arthrotek)
- Ace Orthopedic Manufacturing Co.: 1 (https://510kreport.com/company/ace-orthopedic-manufacturing)

## Firms that cite its devices most
- Biomet, Inc.: 18 (https://510kreport.com/company/biomet)
- Biomet Manufacturing Corp: 13 (https://510kreport.com/company/biomet-manufacturing)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet Trauma: 4 (https://510kreport.com/company/biomet-trauma)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)
- Lima Corporate S.P.A.: 2 (https://510kreport.com/company/lima-corporate)
- Tornier, Inc.: 2 (https://510kreport.com/company/tornier)
- Encore Medical L.P.: 2 (https://510kreport.com/company/encore-medical)

## Its most-cited devices
- K020045: 3-Piece Proximal Humeral Replacement System (2002), cited by 6
- K080528: E-Poly Tibial Bearings (2008), cited by 6
- K023357: Arcpm 1050 Resin-Hips (2002), cited by 5
- K020221: Iql Basic Fragment Plate Set, Iql Basic Fragment Screw Set, Iql Small Fragment Set, Iql Mini Fragment Set (2002), cited by 5
- K023063: Comprehensive Humeral Fracture System (2002), cited by 5
- K013042: Discovery Elbow (2001), cited by 5

## Recent decisions
- K253515: Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments (Aug 24, 2026)
- K252404: Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (Apr 15, 2026)
- K243761: A.L.P.S. Small Fragment Plating System (Feb 19, 2025)
- K223631: Comprehensive Segmental Revision System (SRS) (Jul 12, 2023)
- K200196: Taperloc® Complete Hip Stems (Dec 8, 2020)
- K131393: Mak Oss Femoral Knee Components (Oct 24, 2013)
- K112905: Compress (R) Segmental Humeral Replacement System (May 24, 2012)
- K080528: E-Poly Tibial Bearings (Jun 17, 2008)

Source page: https://510kreport.com/company/biomet-orthopedics