# Biomet, Inc.

- Location (FDA's records): Warsaw, IN
- FDA decisions: 446 (1978–2026): 445 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Biomet, Inc. (443); Biomet (2); Biomet Corporation (1)
- Product codes: JDI (51), LPH (44), JWH (40), HWC (24), LZO (21), HRS (21), KWA (11), KWT (11), MBI (10), HRY (10), KRO (9), HSB (8)
- 510(k) review time since 2016: median 90 days, against 106 for FDA's reviews in the same codes and years (15 of 27 faster)
- Predicates its devices cite: 573 (270 its own); citations of its devices by later devices: 946 (270 its own)
- Recalls linked to its devices: 338 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet Manufacturing Corp: 63 (https://510kreport.com/company/biomet-manufacturing)
- DePuy Orthopaedics, Inc.: 20 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet Orthopedics, Inc.: 18 (https://510kreport.com/company/biomet-orthopedics)
- Zimmer, Inc.: 15 (https://510kreport.com/company/zimmer)
- Depuy, Inc.: 14 (https://510kreport.com/company/depuy)
- Kirschner Medical Corp.: 13 (https://510kreport.com/company/kirschner-medical)
- Howmedica Corp.: 10 (https://510kreport.com/company/howmedica)
- Osteonics Corp.: 9 (https://510kreport.com/company/osteonics)

## Firms that cite its devices most
- Biomet Manufacturing Corp: 165 (https://510kreport.com/company/biomet-manufacturing)
- Biomet Orthopedics, Inc.: 45 (https://510kreport.com/company/biomet-orthopedics)
- Zimmer, Inc.: 29 (https://510kreport.com/company/zimmer)
- Lima Corporate S.P.A.: 23 (https://510kreport.com/company/lima-corporate)
- United Orthopedic Corporation: 17 (https://510kreport.com/company/united-orthopedic)
- Arthrotek, Inc.: 17 (https://510kreport.com/company/arthrotek)
- Smith & Nephew, Inc.: 12 (https://510kreport.com/company/smith-nephew)
- Tornier, Inc.: 11 (https://510kreport.com/company/tornier)

## Its most-cited devices
- K080642: Comprehensive Reverse Shoulder (2008), cited by 24
- K002757: Oncology Salvage System (2000), cited by 21
- K043537: Taperloc 12/14 Taper Femoral Components (2005), cited by 20
- K030710: Bio-Modular Shoulder System (2003), cited by 20
- K023546: Maxim Accel Knee System (2003), cited by 15
- K921301: Taperloc Femoral Stem and Universal Acetabular Com (1994), cited by 14

## Recent decisions
- K253434: OSSTM Orthopedic Salvage System (Jul 1, 2026)
- K251270: Taperloc® Complete Hip Stem (May 19, 2026)
- K241014: Biomet Kirschner Wires (K-Wires) (May 22, 2024)
- K222760: StageOne™ Select Hip Cement Spacer Molds (Dec 28, 2022)
- K221968: StageOne™ Shoulder Cement Spacer Molds (Sep 15, 2022)
- K213287: StageOne Knee Cement Spacer Molds (Sep 2, 2022)
- K212431: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (Feb 7, 2022)
- K212435: Comprehensive Humeral Fracture Positioning Sleeves (Dec 10, 2021)

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