Company · IE
Depuy Ireland UC
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (6 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 8 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 6 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 6 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 6 |
| OLO | Orthopedic Stereotaxic Instrument | 4 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 3 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 1 |
| LZN | Cement Obturator | 1 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 1 |
| QIH | Automated Radiological Image Processing Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2026 | K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System DePuy Ireland UC, IE | JWH |
| Jun 25, 2026 | K260480 | VELYS Robotic-Assisted Solution Depuy Ireland UC, IE | OLO |
| May 15, 2026 | K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement Depuy Ireland UC, IE | KWL |
| Mar 11, 2026 | K253624 | INHANCE Reverse Shoulder System Depuy Ireland UC, IE | PHX |
| Mar 6, 2026 | K253551 | VELYS Hip Navigation Depuy Ireland UC, IE | QIH |
| Nov 19, 2025 | K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors Depuy Ireland UC, IE | JWH |
| May 23, 2025 | K251292 | RECLAIM Monobloc Revision Femoral Stem Depuy Ireland UC, IE | LZO |
| Jan 22, 2025 | K243977 | EMPHASYS Acetabular System Depuy Ireland UC, IE | LPH |
| Dec 23, 2024 | K243248 | INHANCE INTACT Depuy Ireland UC, IE | PKC |
| Nov 21, 2024 | K242871 | ATTUNE Revision Hinge Knee Depuy Ireland UC, IE | KRO |
| Oct 7, 2024 | K242084 | EMPHASYS Acetabular Shell with RapiTite HA Depuy Ireland UC, IE | LPH |
| Jul 11, 2024 | K241000 | ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Depuy Ireland UC, IE | JWH |
| Jun 18, 2024 | K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Tech Depuy Ireland UC, IE | MBH |
| Jun 5, 2024 | K240211 | VELYS Robotic-Assisted Solution Depuy Ireland UC, IE | OLO |
| Apr 4, 2024 | K240639 | PINNACLETM Constrained Acetabular Liners Depuy Ireland UC, GB | KWZ |
| Mar 21, 2024 | K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Parti Depuy Ireland UC, IE | KRO |
| Feb 15, 2024 | K231522 | EMPHASYS Dual Mobility System Depuy Ireland UC, IE | LPH |
| Jan 19, 2024 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Depuy Ireland UC, IE | MEH |
| Dec 19, 2023 | K231526 | CORAIL Cemented Femoral Stem Depuy Ireland UC, IE | KWY |
| Dec 14, 2023 | K233227 | VELYS Robotic-Assisted Solution Depuy Ireland UC, IE | OLO |
| Dec 11, 2023 | K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Tec Depuy Ireland UC, IE | MBH |
| Nov 13, 2023 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid Depuy Ireland UC, IE | MBF |
| Oct 11, 2023 | K233233 | EMPHASYS Femoral Stems Depuy Ireland UC, IE | LZO |
| Sep 20, 2023 | K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System Depuy Ireland UC, IE | LPH |
| Jul 21, 2023 | K231516 | INHANCE Shoulder System, Sterile Single Use Instrumentation Depuy Ireland UC, IE | MBF |
| Mar 10, 2023 | K230295 | ATTUNE® Revision Cones Depuy Ireland UC, IE | MBH |
| Jan 6, 2023 | K222296 | ARTICUL/EZE Ceramic Heads Depuy Ireland UC, IE | LZO |
| Dec 2, 2022 | K223211 | INHANCETM Shoulder System Humeral Stems and Stemless Depuy Ireland UC, IE | PHX |
| Oct 21, 2022 | K221462 | DePuy Reclaim Monobloc Revision Femoral Stem Depuy Ireland UC, IE | LZO |
| Oct 17, 2022 | K212746 | ATTUNE Revision Cones Depuy Ireland UC, IE | MBH |
| Sep 6, 2022 | K221636 | EMPHASYS Acetabular System Depuy Ireland UC, IE | LPH |
| Aug 31, 2022 | K221467 | INHANCETM Reverse Glenoid Peripheral Posts Depuy Ireland UC, IE | PHX |
| Jul 22, 2022 | K220216 | C-Stem AMT LE Prosthesis Depuy Ireland UC, IE | JDI |
| Jun 8, 2022 | K212933 | INHANCETM Hybrid Anatomic Glenoid Implant Depuy Ireland UC, IE | MBF |
| Apr 21, 2022 | K212737 | INHANCE Reverse Shoulder System Depuy Ireland UC, IE | PHX |
| Jan 18, 2022 | K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP Depuy Ireland UC, IE | MBH |
| Sep 15, 2021 | K212710 | GLOBAL UNITE Platform Shoulder System Depuy Ireland UC, IE | PHX |
| Aug 25, 2021 | K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert Depuy Ireland UC, IE | JWH |
| Aug 5, 2021 | K211657 | EMPHASYS Femoral Stems Depuy Ireland UC, IE | LZO |
| Jul 22, 2021 | K203694 | DELTA XTEND Reverse Shoulder System Depuy Ireland UC, IE | PHX |
| May 20, 2021 | K210581 | Actis DuoFix Hip Prosthesis- Collarless Depuy Ireland UC, IE | MEH |
| Apr 28, 2021 | K203532 | BI-MENTUM ALTRX® Dual Mobility Liner Depuy Ireland UC, IE | LZO |
| Jan 14, 2021 | K202769 | VELYS Robotic-Assisted Solution Depuy Ireland UC, IE | OLO |
| Dec 28, 2020 | K202248 | Attune Revision Sleeve LPS Femoral Adaptors Depuy Ireland UC, IE | JWH |
| Nov 25, 2020 | K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Te Depuy Ireland UC, IE | MBH |
| Nov 25, 2020 | K202098 | GLOBAL UNITE Platform Shoulder System Depuy Ireland UC, IE | PHX |
| Sep 11, 2020 | K200854 | DePuy PINNACLE Dual Mobility Liner Depuy Ireland UC, IE | LPH |
| Apr 16, 2020 | K193549 | SIGMA High Performance (HP) Partial Knee System Depuy Ireland UC, IE | HRY |
| Jan 30, 2020 | K193057 | ATTUNE All-Polyethylene Tibia Depuy Ireland UC, IE | JWH |
| Jan 11, 2018 | K170748 | GLOBAL UNITE Platform Shoulder System Depuy Ireland UC, IE | PHX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2023 | Depuy Ireland UC BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR
Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size Open, Classified |
LZN | K943727 |