510(k) K962557 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
| Applicant | Smith & Nephew Richards, Inc., Memphis TN, US |
| Decision | Substantially Equivalent for Some Indications, Dec 5, 1996 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2024 | Smith & Nephew Inc smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.