Company ยท IE
Depuy(Ireland)
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2022. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
11recalls (11 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 12 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 4 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2022 | K212683 | GLOBAL ICON Stemless Shoulder System Depuy(Ireland), IE | PKC |
| Feb 24, 2020 | K192855 | DELTA XTEND(TM) Reverse Shoulder System Depuy(Ireland), IE | PHX |
| Nov 1, 2019 | K190344 | DePuy Corail AMT Hip Prosthesis Depuy(Ireland), IE | LZO |
| Oct 8, 2019 | K191779 | Attune Revision LPS Inserts Depuy(Ireland), IE | KRO |
| Oct 4, 2019 | K192448 | Delta Xtend Revers Shoulder System Depuy(Ireland), IE | PHX |
| May 17, 2019 | K183077 | Delta Xtend Reverse Shoulder System Depuy(Ireland), IE | PHX |
| Jun 15, 2017 | K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing Depuy(Ireland), IE | JWH |
| Jul 19, 2016 | K160907 | DePuy Actis DuoFix Hip Prosthesis Depuy(Ireland), IE | MEH |
| Jun 10, 2016 | K160700 | ATTUNE Revision Knee System Depuy(Ireland), IE | JWH |
| Feb 13, 2015 | K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS Depuy(Ireland), IE | MBH |
| Apr 3, 2014 | K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM Depuy(Ireland), IE | KWS |
| Dec 15, 2010 | K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM Depuy(Ireland), IE | PHX |
| Nov 23, 2010 | K102080 | DEPUY RECLAIM REVISION HIP SYSTEM Depuy(Ireland) | LZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes.
1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410.
2 Open, Classified |
KRO | K242871 |
| Jun 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes.
1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Numb Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105. Open, Classified |
KRO | K242871 |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104. Open, Classified |
KRO | K242871 |