Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DePuy Ireland UC · Predicate Candidate Screening

50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

103 daysmedian FDA review time
234 days90th percentile
50clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC2026-06-25550
K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC2026-06-251320
K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CemeDepuy Ireland UC2026-05-15870
K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC2026-03-111130
K253551VELYS™ Hip NavigationDepuy Ireland UC2026-03-061120
K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ FemoDepuy Ireland UC2025-11-19540
K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC2025-05-23280
K243977EMPHASYS Acetabular SystemDepuy Ireland UC2025-01-22300
K243248INHANCE INTACT™Depuy Ireland UC2024-12-23730
K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC2024-11-215911
K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC2024-10-07830
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System UDepuy Ireland UC2024-07-11900
K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome PaDepuy Ireland UC2024-06-18990
K240211VELYS Robotic-Assisted SolutionDepuy Ireland UC2024-06-051320
K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC2024-04-04290
K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPSDepuy Ireland UC2024-03-21940
K231522EMPHASYS™ Dual Mobility SystemDepuy Ireland UC2024-02-152650
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuyDepuy Ireland UC2024-01-192070
K231526CORAIL Cemented Femoral StemDepuy Ireland UC2023-12-192070
K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC2023-12-14770
K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome PaDepuy Ireland UC2023-12-111321
K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCEDepuy Ireland UC2023-11-132310
K233233EMPHASYS Femoral StemsDepuy Ireland UC2023-10-11130
K232556DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlanDepuy Ireland UC2023-09-20280
K231516INHANCE™ Shoulder System, Sterile Single Use InstrumentationDepuy Ireland UC2023-07-21570
K230295ATTUNE® Revision ConesDepuy Ireland UC2023-03-10360
K222296ARTICUL/EZE Ceramic HeadsDepuy Ireland UC2023-01-061580
K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC2022-12-02460
K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC2022-10-211550
K212746ATTUNE Revision ConesDepuy Ireland UC2022-10-174130
K221636EMPHASYS Acetabular SystemDepuy Ireland UC2022-09-06920
K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC2022-08-311030
K220216C-Stem AMT LE ProsthesisDepuy Ireland UC2022-07-221770
K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC2022-06-082660
K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC2022-04-212340
K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC2022-01-18461
K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC2021-09-15200
K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC2021-08-25920
K211657EMPHASYS Femoral StemsDepuy Ireland UC2021-08-05690
K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC2021-07-222160
K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC2021-05-20830
K203532BI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UC2021-04-281470
K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC2021-01-141150
K202248Attune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UC2020-12-281400
K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC2020-11-251190
K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome PaDepuy Ireland UC2020-11-251121
K200854DePuy PINNACLE Dual Mobility LinerDepuy Ireland UC2020-09-111640
K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC2020-04-161180
K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC2020-01-30900
K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018-01-113070

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda