510(k) K242871 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
ATTUNE Revision Hinge Knee
| Applicant | Depuy Ireland UC, Ringaskiddy, IE |
| Decision | Substantially Equivalent, Nov 21, 2024 |
| Received | Sep 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242871
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207. Open, Classified |
KRO | None listed |
| Apr 29, 2026 | DEPUY (IRELAND) Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208. Open, Classified |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.