FDA 510(k) Applications Submitted by DePuy Ireland UC

FDA 510(k) Number Submission Date Device Name Applicant
K231526 05/26/2023 CORAIL Cemented Femoral Stem DePuy Ireland UC
K243977 12/23/2024 EMPHASYS Acetabular System DePuy Ireland UC
K233227 09/28/2023 VELYSÖ Robotic-Assisted Solution DePuy Ireland UC
K211609 05/25/2021 ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert DePuy Ireland UC
K170748 03/10/2017 GLOBAL UNITE Platform Shoulder System DePuy Ireland UC
K240678 03/11/2024 ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology Depuy Ireland UC
K210581 02/26/2021 Actis DuoFix Hip Prosthesis- Collarless DePuy Ireland UC
K221636 06/06/2022 EMPHASYS Acetabular System DePuy Ireland UC
K242084 07/16/2024 EMPHASYS Acetabular Shell with RapiTite HA DePuy Ireland UC
K240211 01/25/2024 VELYS Robotic-Assisted Solution DePuy Ireland UC
K200854 03/31/2020 DePuy PINNACLE Dual Mobility Liner DePuy Ireland UC
K211657 05/28/2021 EMPHASYS Femoral Stems DePuy Ireland UC
K202194 08/05/2020 ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology DePuy Ireland UC
K202248 08/10/2020 Attune Revision Sleeve LPS Femoral Adaptors DePuy Ireland UC
K212746 08/30/2021 ATTUNE Revision Cones Depuy Ireland UC
K202769 09/21/2020 VELYSÖ Robotic-Assisted Solution DePuy Ireland UC
K203532 12/02/2020 BI-MENTUMÖ ALTRX« Dual Mobility Liner Depuy Ireland UC
K213781 12/03/2021 ATTUNE« Porous Fixed Bearing Tibial Base with AFFIXIUMÖ 3DP DePuy Ireland UC
K193549 12/20/2019 SIGMA High Performance (HP) Partial Knee System DePuy Ireland UC
K231522 05/26/2023 EMPHASYSÖ Dual Mobility System DePuy Ireland UC
K203694 12/18/2020 DELTA XTEND Reverse Shoulder System DePuy Ireland UC
K240639 03/06/2024 PINNACLETM Constrained Acetabular Liners Depuy Ireland UC
K221462 05/19/2022 DePuy Reclaim Monobloc Revision Femoral Stem DePuy Ireland UC
K231873 06/26/2023 DePuy SUMMIT Porocoat Hip Prosthesis û MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis û MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis û MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis û MR Conditional, DePuy SUMMIT Basic Press-Fit Hip P DePuy Ireland UC
K202098 07/29/2020 GLOBAL UNITEÖ Platform Shoulder System DePuy Ireland UC
K230295 02/02/2023 ATTUNE« Revision Cones DePuy Ireland UC
K232303 08/01/2023 ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology DePuy Ireland UC
K193057 11/01/2019 ATTUNE All-Polyethylene Tibia DePuy Ireland UC
K241000 04/12/2024 ATTUNEÖ 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-ROMÖ NOILESÖ Rotating H DePuy Ireland UC
K233980 12/18/2023 ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System DePuy Ireland UC
K222296 08/01/2022 ARTICUL/EZE Ceramic Heads Depuy Ireland UC
K242871 09/23/2024 ATTUNEÖ Revision Hinge Knee DePuy Ireland UC
K251292 04/25/2025 RECLAIM Monobloc Revision Femoral Stem DePuy Ireland UC
K243248 10/11/2024 INHANCE INTACTÖ Depuy Ireland UC
K220216 01/26/2022 C-Stem AMT LE Prosthesis DePuy Ireland UC
K233233 09/28/2023 EMPHASYS Femoral Stems DePuy Ireland UC
K232556 08/23/2023 DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System Depuy Ireland UC
K230831 03/27/2023 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid Depuy Ireland UC
K221467 05/20/2022 INHANCETM Reverse Glenoid Peripheral Posts Depuy Ireland UC
K231516 05/25/2023 INHANCEÖ Shoulder System, Sterile Single Use Instrumentation Depuy Ireland UC
K212710 08/26/2021 GLOBAL UNITEÖ Platform Shoulder System DePuy Ireland UC
K212737 08/30/2021 INHANCEÖ Reverse Shoulder System Depuy Ireland UC
K212933 09/15/2021 INHANCETM Hybrid Anatomic Glenoid Implant Depuy Ireland UC
K223211 10/17/2022 INHANCETM Shoulder System û Humeral Stems and Stemless Depuy Ireland UC


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