510(k) K172634 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
| Applicant | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Nov 16, 2017 |
| Received | Sep 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 6 11 MM Open, Classified |
MBH | None listed |
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 7 9 MM Open, Classified |
MBH | None listed |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Open, Classified |
MBH | None listed |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM Open, Classified |
MBH | None listed |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Open, Classified |
MBH | None listed |
| Mar 6, 2024 | Howmedica Osteonics Corp. NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM Open, Classified |
MBH | None listed |
| May 30, 2023 | Howmedica Osteonics Corp. TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement
Catalog Number: 5532-G-413-E Open, Classified |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.