510(k) K053514 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TRIATHLON TOTAL KNEE SYSTEM
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 26, 2006 |
| Received | Dec 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053514
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2013 | Stryker Howmedica Osteonics Corp. Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE Terminated |
LXH | None listed |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Triathlon Cemented Stem - Knee
These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total kn Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.