# Depuy (Ireland)

- Location (FDA's records): Cork, IE
- FDA decisions: 13 (2010–2022): 13 510(k) clearances
- Product codes: PHX (4), JWH (2), LZO (2), MBH (1), KWS (1), PKC (1), KRO (1), MEH (1)
- 510(k) review time since 2016: median 109 days, against 144 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 39 (1 its own); citations of its devices by later devices: 36 (1 its own)
- Recalls linked to its devices: 32 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DePuy Orthopaedics, Inc.: 23 (https://510kreport.com/company/depuy-orthopaedics)
- Tornier, Inc.: 6 (https://510kreport.com/company/tornier)
- Depuy France S.A.S.: 5 (https://510kreport.com/company/depuy-france)
- Johnson & Johnson Professionals, Inc.: 1 (https://510kreport.com/company/johnson-johnson-professionals)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Depuy Ireland UC: 1 (https://510kreport.com/company/depuy-ireland-uc)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)

## Firms that cite its devices most
- Depuy Ireland UC: 16 (https://510kreport.com/company/depuy-ireland-uc)
- DePuy Orthopaedics, Inc.: 5 (https://510kreport.com/company/depuy-orthopaedics)
- Medacta International S.A.: 3 (https://510kreport.com/company/medacta-international)
- Serf: 2 (https://510kreport.com/company/serf)
- Signature Orthopaedics Pty, Ltd.: 2 (https://510kreport.com/company/signature-orthopaedics)
- Waldemar Link GmbH & Co. KG: 1 (https://510kreport.com/company/waldemar-link)
- Stryker Orthopaedics: 1 (https://510kreport.com/company/stryker-orthopaedics)
- Microport Orthopedics, Inc.: 1 (https://510kreport.com/company/microport-orthopedics)

## Its most-cited devices
- K160907: DePuy Actis DuoFix Hip Prosthesis (2016), cited by 10
- K101996: Depuy Global Unite Shoulder System (2010), cited by 4
- K160700: ATTUNE Revision Knee System (2016), cited by 4
- K140881: Depuy Attune Knee System - Cementless CR and PS Femoral Componenets (2015), cited by 3
- K102080: Depuy Reclaim Revision Hip System (2010), cited by 3
- K190344: DePuy Corail AMT Hip Prosthesis (2019), cited by 3

## Recent decisions
- K212683: GLOBAL ICON Stemless Shoulder System (Jan 19, 2022)
- K192855: DELTA XTEND (TM) Reverse Shoulder System (Feb 24, 2020)
- K190344: DePuy Corail AMT Hip Prosthesis (Nov 1, 2019)
- K191779: Attune Revision LPS Inserts (Oct 8, 2019)
- K192448: Delta Xtend Revers Shoulder System (Oct 4, 2019)
- K183077: Delta Xtend Reverse Shoulder System (May 17, 2019)
- K170806: ATTUNE Cemented Tibial Base, Fixed Bearing (Jun 15, 2017)
- K160907: DePuy Actis DuoFix Hip Prosthesis (Jul 19, 2016)

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