510(k) K060525 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
VANGUARD REMOVABLE MOLDED POLY TIBIA
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, May 25, 2006 |
| Received | Feb 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2020 | Biomet, Inc. Knee Products:
189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM
189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM
189320 Vanguard Knee System, CR-L Mono Terminated |
JWH | None listed |
| Apr 17, 2020 | Biomet, Inc. Knee Products:
189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM
189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM
189442 Vanguard Knee System, PS Mono Lock Terminated |
JWH | None listed |
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Knees
Revision Tibial Tray Systems
Oxford Partial Knee
Orthopedic Salvage System
Vanguard Complete Knee System
Vanguard SSK Revision System
Biomet Patella
Maxim Complete Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.