510(k) K031729 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 2, 2003 |
| Received | Jun 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031729
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2011 | Stryker Howmedica Osteonics Corp. Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary o Terminated |
JWH | None listed |
| 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 |
| Mar 2, 2010 | Stryker Howmedica Osteonics Corp. Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ.
Intended to be used with femoral components in primary or revision total knee arthroplast Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.