# DePuy Orthopaedics, Inc.

- Location (FDA's records): Warsaw, IN
- FDA decisions: 213 (1998–2026): 210 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: DePuy Orthopaedics, Inc. (210); Depuy Orthopaedics (2); Depuy Orthopaedics, Inc. (1)
- Product codes: LPH (33), HRS (18), LZO (17), JWH (16), JDI (12), KWA (12), HSB (9), KWS (9), LOD (9), KTT (7), PHX (6), HRY (5)
- 510(k) review time since 2016: median 57 days, against 138 for FDA's reviews in the same codes and years (8 of 12 faster)
- Predicates its devices cite: 497 (216 its own); citations of its devices by later devices: 744 (216 its own)
- Recalls linked to its devices: 633 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy, Inc.: 84 (https://510kreport.com/company/depuy)
- Johnson & Johnson Professionals, Inc.: 39 (https://510kreport.com/company/johnson-johnson-professionals)
- Ace Medical Co.: 12 (https://510kreport.com/company/ace-medical)
- Zimmer, Inc.: 12 (https://510kreport.com/company/zimmer)
- Buckman Co., Inc.: 9 (https://510kreport.com/company/buckman)
- Hand Innovations, Inc.: 8 (https://510kreport.com/company/hand-innovations)
- Howmedica Osteonics Corp.: 8 (https://510kreport.com/company/howmedica-osteonics)
- Synthes (Usa): 7 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- Depuy Ireland UC: 82 (https://510kreport.com/company/depuy-ireland-uc)
- Depuy (Ireland): 23 (https://510kreport.com/company/depuy-ireland)
- Biomet, Inc.: 20 (https://510kreport.com/company/biomet)
- Exactech, Inc.: 15 (https://510kreport.com/company/exactech)
- Depuy Lnc.: 15 (https://510kreport.com/company/depuy-lnc)
- Corentec Co., Ltd.: 14 (https://510kreport.com/company/corentec)
- Smith & Nephew, Inc.: 14 (https://510kreport.com/company/smith-nephew)
- Medacta International S.A.: 13 (https://510kreport.com/company/medacta-international)

## Its most-cited devices
- K042992: Corail Amt Hip Prosthesis (2005), cited by 27
- K000306: Pinnacle Acetabular System (2000), cited by 18
- K062250: Delta Xtend Reverse Shoulder System (2007), cited by 17
- K001534: Pinnacle Acetabular System (2000), cited by 15
- K101433: Depuy Attune Knee System (2010), cited by 15
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head (1999), cited by 14

## Recent decisions
- K262130: ATTUNE Revision Knee System (Sep 4, 2026)
- K252887: DePuy ATTUNE™ Knee System (May 22, 2026)
- K231503: CUPTIMIZE™ Advanced (Aug 22, 2023)
- K213839: DePuy Corail AMT Hip Prosthesis (Jan 6, 2022)
- K210167: DELTA XTEND Reverse Shoulder System (Feb 19, 2021)
- K203167: DePuy Corail AMT Hip Prosthesis (Nov 19, 2020)
- K202472: ACTIS Duofix Hip Prosthesis (Oct 21, 2020)
- K201347: DePuy ATTUNE™ Total Knee System (Jun 18, 2020)

Source page: https://510kreport.com/company/depuy-orthopaedics