Depuy Ireland UC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
47
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0951-2023Class IIBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10December 19, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K253624INHANCE™ Reverse Shoulder SystemMarch 11, 2026
K253551VELYS™ Hip NavigationMarch 6, 2026
K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsNovember 19, 2025
K251292RECLAIM Monobloc Revision Femoral StemMay 23, 2025
K243977EMPHASYS Acetabular SystemJanuary 22, 2025
K243248INHANCE INTACT™December 23, 2024
K242871ATTUNE™ Revision Hinge KneeNovember 21, 2024
K242084EMPHASYS Acetabular Shell with RapiTite HAOctober 7, 2024
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal July 11, 2024
K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella wiJune 18, 2024
K240211VELYS Robotic-Assisted SolutionJune 5, 2024
K240639PINNACLETM Constrained Acetabular LinersApril 4, 2024
K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High PeMarch 21, 2024
K231522EMPHASYS™ Dual Mobility SystemFebruary 15, 2024
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR CondiJanuary 19, 2024
K231526CORAIL Cemented Femoral StemDecember 19, 2023
K233227VELYS™ Robotic-Assisted SolutionDecember 14, 2023
K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella wiDecember 11, 2023
K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidNovember 13, 2023
K233233EMPHASYS Femoral StemsOctober 11, 2023