510(k) K043440 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Dec 14, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2024 | Smith & Nephew Inc smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Open, Classified |
JWH | None listed |
| Oct 30, 2024 | Smith & Nephew Inc smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Open, Classified |
JWH | None listed |
| May 19, 2021 | Smith & Nephew, Inc. LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis compon Terminated |
JWH | None listed |
| Jan 15, 2018 | Smith & Nephew, Inc. LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432
Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, whe Completed |
JWH | None listed |
| Jan 18, 2016 | Smith & Nephew, Inc. LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment. Terminated |
JWH | None listed |
| Aug 23, 2009 | Smith & Nephew Inc LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116.
The device is used for Orthopedic Knee Implants. Terminated |
JWH | None listed |
| Aug 23, 2009 | Smith & Nephew Inc LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116.
The device is used for Orthopedic Knee Implants. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.