510(k) K051380 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 30, 2005 |
| Received | May 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2009 | Stryker Howmedica Osteonics Corp. Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile.
Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary o Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.