510(k) K051977 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 12, 2005 |
| Received | Jul 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051977
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2010 | Stryker Howmedica Osteonics Corp. Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ.
Intended to be used with cemented or cementless components in primary or Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.