510(k) K071071 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Sep 19, 2007 |
| Received | Apr 16, 2007 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K071071
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2019 | Smith & Nephew, Inc. LEGION PS High Flex XLPE size 5-6 9mm Articular Insert Terminated |
JWH | None listed |
| Mar 30, 2018 | Smith & Nephew, Inc. smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligam Terminated |
JWH | None listed |
| Mar 30, 2018 | Smith & Nephew, Inc. smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligam Terminated |
JWH | None listed |
| Mar 30, 2018 | Smith & Nephew, Inc. smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligame Terminated |
JWH | None listed |
| Mar 30, 2018 | Smith & Nephew, Inc. smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligamen Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.