# Depuy Ireland UC

- Location (FDA's records): Ringaskiddy, IE
- FDA decisions: 50 (2018–2026): 50 510(k) clearances
- Names in FDA's records: Depuy Ireland UC (49); DePuy Ireland UC (1)
- Product codes: PHX (8), LZO (6), LPH (6), JWH (6), MBH (6), OLO (4), MBF (3), KRO (2), MEH (2), HRY (1), KWY (1), PKC (1)
- 510(k) review time since 2016: median 101 days, against 112 for FDA's reviews in the same codes and years (23 of 46 faster)
- Predicates its devices cite: 220 (36 its own); citations of its devices by later devices: 52 (36 its own)
- Recalls linked to its devices: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DePuy Orthopaedics, Inc.: 82 (https://510kreport.com/company/depuy-orthopaedics)
- Depuy, Inc.: 22 (https://510kreport.com/company/depuy)
- Johnson & Johnson Professionals, Inc.: 17 (https://510kreport.com/company/johnson-johnson-professionals)
- Depuy (Ireland): 16 (https://510kreport.com/company/depuy-ireland)
- Joint Medical Products Corp.: 10 (https://510kreport.com/company/joint-medical-products)
- Ignite Orthopedics, LLC: 7 (https://510kreport.com/company/ignite-orthopedics)
- Depuy France S.A.S.: 4 (https://510kreport.com/company/depuy-france)
- Encore Medical L.P.: 3 (https://510kreport.com/company/encore-medical)

## Firms that cite its devices most
- Globus Medical, Inc.: 4 (https://510kreport.com/company/globus-medical)
- Medacta International S.A.: 3 (https://510kreport.com/company/medacta-international)
- Shoulder Innovations, Inc.: 2 (https://510kreport.com/company/shoulder-innovations)
- Waldemar Link GmbH & Co. KG: 1 (https://510kreport.com/company/waldemar-link)
- Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.: 1 (https://510kreport.com/company/symmetry-medical-manufacturing-dba-tecomet)
- Restor3D: 1 (https://510kreport.com/company/restor3d)
- Depuy (Ireland): 1 (https://510kreport.com/company/depuy-ireland)
- Implantcast GmbH: 1 (https://510kreport.com/company/implantcast)

## Its most-cited devices
- K212737: INHANCE™ Reverse Shoulder System (2022), cited by 7
- K210581: Actis DuoFix Hip Prosthesis- Collarless (2021), cited by 6
- K170748: GLOBAL UNITE Platform Shoulder System (2018), cited by 5
- K202194: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (2020), cited by 4
- K221636: EMPHASYS Acetabular System (2022), cited by 4
- K220216: C-Stem AMT LE Prosthesis (2022), cited by 3

## Recent decisions
- K260480: VELYS™ Robotic-Assisted Solution (Jun 25, 2026)
- K261458: ATTUNE Total Knee System; ATTUNE Cementless Knee System (Jun 25, 2026)
- K260536: Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (May 15, 2026)
- K253624: INHANCE™ Reverse Shoulder System (Mar 11, 2026)
- K253551: VELYS™ Hip Navigation (Mar 6, 2026)
- K253197: ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (Nov 19, 2025)
- K251292: RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
- K243977: EMPHASYS Acetabular System (Jan 22, 2025)

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