510(k) K081111 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
LEGION HINGE KNEE SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jul 23, 2008 |
| Received | Apr 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2018 | Smith & Nephew, Inc. smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE
The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arth Terminated |
KRO | None listed |
| May 26, 2016 | Smith & Nephew, Inc. LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373
The LEGION Hinge Knee System is indicated for:
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, Terminated |
KRO | None listed |
| May 26, 2016 | Smith & Nephew, Inc. LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363
The LEGION Hinge Knee System is indicated for:
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, Terminated |
KRO | None listed |
| May 26, 2016 | Smith & Nephew, Inc. LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374
The LEGION Hinge Knee System is indicated for:
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, Terminated |
KRO | None listed |
| May 26, 2016 | Smith & Nephew, Inc. LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364
The LEGION Hinge Knee System is indicated for:
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, Terminated |
KRO | None listed |
| May 26, 2016 | Smith & Nephew, Inc. LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375
The LEGION Hinge Knee System is indicated for:
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or Terminated |
KRO | None listed |
| May 26, 2016 | Smith & Nephew, Inc. LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365
The LEGION Hinge Knee System is indicated for:
1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, o Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.