510(k) K121393 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 7, 2012 |
| Received | May 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2019 | Smith & Nephew, Inc. LEGION AP Cutting Block Size 4, REF 71434409;
LEGION AP Cutting Block Size 6, REF 71434411;
LEGION AP Cutting Block Size 7, REF 71434412;
LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic man Open, Classified |
MBH | None listed |
| Sep 18, 2018 | Smith & Nephew, Inc. Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1)
The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the d Terminated |
MBH | None listed |
| May 4, 2018 | Smith & Nephew, Inc. smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) Terminated |
MBH | None listed |
| Apr 9, 2018 | Smith & Nephew, Inc. smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014
The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthr Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.