# Biomet Manufacturing Corp

- Location (FDA's records): Warsaw, IN
- FDA decisions: 129 (1999–2023): 128 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Biomet Manufacturing Corp (94); Biomet Manufacturing, Inc. (32); Biomet Manufacturing, LLC (2); Biomet Manufacturing (1)
- Product codes: PHX (15), KWA (14), JWH (12), MBI (7), MBH (6), LPH (6), KRO (5), HRS (5), HWC (5), MBF (4), HRY (4), JDR (4)
- 510(k) review time since 2016: median 143 days, against 130 for FDA's reviews in the same codes and years (5 of 12 faster)
- Predicates its devices cite: 362 (53 its own); citations of its devices by later devices: 302 (53 its own)
- Recalls linked to its devices: 217 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet, Inc.: 165 (https://510kreport.com/company/biomet)
- Biomet Orthopedics, Inc.: 13 (https://510kreport.com/company/biomet-orthopedics)
- DePuy Orthopaedics, Inc.: 12 (https://510kreport.com/company/depuy-orthopaedics)
- Zimmer, Inc.: 10 (https://510kreport.com/company/zimmer)
- Howmedica Osteonics Corp.: 10 (https://510kreport.com/company/howmedica-osteonics)
- Wrightmedicaltechnologyinc: 8 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Arthrotek, Inc.: 8 (https://510kreport.com/company/arthrotek)
- Implex Corp.: 7 (https://510kreport.com/company/implex)

## Firms that cite its devices most
- Biomet, Inc.: 63 (https://510kreport.com/company/biomet)
- Zimmer, Inc.: 22 (https://510kreport.com/company/zimmer)
- Lima Corporate S.P.A.: 13 (https://510kreport.com/company/lima-corporate)
- Medacta International S.A.: 8 (https://510kreport.com/company/medacta-international)
- Waldemar Link GmbH & Co. KG: 7 (https://510kreport.com/company/waldemar-link)
- Biomet Orthopedics, Inc.: 6 (https://510kreport.com/company/biomet-orthopedics)
- Shoulder Innovations, Inc.: 6 (https://510kreport.com/company/shoulder-innovations)
- Arthrex, Inc.: 5 (https://510kreport.com/company/arthrex)

## Its most-cited devices
- K113550: Vanguard Complete Knee System (2012), cited by 18
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), cited by 17
- K060692: Comprehensive Primary Shoulder Stems (2006), cited by 15
- K121874: G7 Acetabular System (2012), cited by 11
- K110400: Taperloc Complete Microplasty Stem (2011), cited by 9
- K040770: Vanguard Patella Components (2004), cited by 8

## Recent decisions
- K230540: Patient Specific Planning Solution™ 3D Bone Models (Jul 25, 2023)
- K214001: Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (Mar 15, 2023)
- K211729: Comprehensive® Convertible Glenoid - Vivacit-E Liner (Nov 4, 2021)
- K202232: Comprehensive Vault Reconstruction System (Feb 19, 2021)
- K193038: Comprehensive Shoulder System (Oct 28, 2020)
- K182516: Comprehensive Nano Stemless Shoulder (Apr 22, 2019)
- K181611: Comprehensive Reverse Shoulder System (Sep 24, 2018)
- K173411: Comprehensive Segmental Revision System (SRS) (Feb 8, 2018)

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