510(k) K173849 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Triathlon Total Knee System
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 2, 2018 |
| Received | Dec 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173849
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 3 10 MM Open, Classified |
MBH | None listed |
| Mar 6, 2024 | Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT NO 6 10 MM Open, Classified |
MBH | None listed |
| May 30, 2023 | Howmedica Osteonics Corp. TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement
Catalog Number: 5531-G-312-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.