510(k) K213781 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP
| Applicant | Depuy Ireland UC, Ringaskiddy, IE |
| Decision | Substantially Equivalent, Jan 18, 2022 |
| Received | Dec 3, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213781
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | DePuy Orthopaedics, Inc. ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System. Open, Classified |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.