Depuy Ireland UC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
48
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
K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementMay 15, 2026
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