510(k) K042515 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Mar 14, 2005 |
| Received | Sep 16, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2018 | Smith & Nephew, Inc. Journey BCS Knee CoCr Femoral Components, Catalog Numbers:
74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 7 Open, Classified |
JWH | None listed |
| Oct 1, 2018 | Smith & Nephew, Inc. JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 7402112 Open, Classified |
JWH | None listed |
| Oct 1, 2018 | Smith & Nephew, Inc. JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 7402312 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.