510(k) K951987 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GENESIS II TOTAL KNEE SYSTEM
| Applicant | Smith & Nephew Richards, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 22, 1995 |
| Received | Apr 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2022 | Smith & Nephew, Inc. (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186.
(2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166. Terminated |
JWH | None listed |
| Aug 8, 2020 | Smith & Nephew, Inc. Tibial knee prosthesis Open, Classified |
JWH | None listed |
| Aug 1, 2017 | Smith & Nephew, Inc. GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis Terminated |
JWH | None listed |
| Jan 4, 2016 | Smith & Nephew, Inc. Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490
knee implant. Terminated |
JWH | None listed |
| Nov 1, 2013 | Smith & Nephew Inc GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168.
Product Usage: orthopaedic Terminated |
JWH | None listed |
| Nov 1, 2013 | Smith & Nephew Inc GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188.
Product Usage: orthopaedic Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.