510(k) K051146 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TRIATHLON KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jul 13, 2005 |
| Received | May 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2009 | Stryker Howmedica Osteonics Corp. Triathlon X3 Posterior Stabilized Tibial Insert
Use with Triathlon PS Femoral Components.
Sze 7, THKNS 13 m and SZE 8, THKNS 13mm;
Catalog number 5532-G-713, Catalog number 5532-G-813
Stryker Orthopae Terminated |
JWH | None listed |
| Feb 8, 2007 | Stryker Howmedica Osteonics Corp. Triathlon X3 CR Tibial Bearing Insert
for knee prosthesis
Size #2 - 11MM
Ref # 5530-G-211
2011-09
Howmedica Osteonics Corp. Terminated |
JWH | None listed |
| Feb 8, 2007 | Stryker Howmedica Osteonics Corp. Triathlon X3 CR Tibial Bearing Insert
Size #7 - 11MM
Ref # 5530-G-711
2011-09
Howmedica Osteonics Corp. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.