Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

DePuy Ireland UC

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K261458 ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH2026-06-25 View
510(k) K260480 VELYS™ Robotic-Assisted SolutionOLO2026-06-25 View
510(k) K260536 Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL2026-05-15 View
510(k) K253624 INHANCE™ Reverse Shoulder SystemPHX2026-03-11 View
510(k) K253551 VELYS™ Hip NavigationQIH2026-03-06 View
510(k) K253197 ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsJWH2025-11-19 View
510(k) K251292 RECLAIM Monobloc Revision Femoral StemLZO2025-05-23 View
510(k) K243977 EMPHASYS Acetabular SystemLPH2025-01-22 View
510(k) K243248 INHANCE INTACT™PKC2024-12-23 View
510(k) K242871 ATTUNE™ Revision Hinge KneeKRO2024-11-21 View
510(k) K242084 EMPHASYS Acetabular Shell with RapiTite HALPH2024-10-07 View
510(k) K241000 ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;JWH2024-07-11 View
510(k) K240678 ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP TechnologyMBH2024-06-18 View
510(k) K240211 VELYS Robotic-Assisted SolutionOLO2024-06-05 View
510(k) K240639 PINNACLETM Constrained Acetabular LinersKWZ2024-04-04 View
510(k) K233980 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemKRO2024-03-21 View
510(k) K231522 EMPHASYS™ Dual Mobility SystemLPH2024-02-15 View
510(k) K231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalMEH2024-01-19 View
510(k) K231526 CORAIL Cemented Femoral StemKWY2023-12-19 View
510(k) K233227 VELYS™ Robotic-Assisted SolutionOLO2023-12-14 View
↑