510(k) K040267 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, May 5, 2004 |
| Received | Feb 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2010 | Stryker Howmedica Osteonics Corp. Triathlon Total Knee System Primary Tibial Baseplate;
Sterile, Made in Ireland.
Howmedica Osteonics
325 Corporate Drive
Mahwah, NJ 07430
The Triathlon system is comprised of a femoral component, tib Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.