510(k) K042993 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 12, 2005 |
| Received | Nov 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042993
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.