510(k) K202194 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
| Applicant | Depuy Ireland UC, Cork, IE |
| Decision | Substantially Equivalent, Nov 25, 2020 |
| Received | Aug 5, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202194
| 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.