510(k) K142933 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet Tibial trays
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 23, 2014 |
| Received | Oct 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142933
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2018 | Zimmer Biomet, Inc. Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340
Product is used in Total Knee Arthroplasty Terminated |
JWH | None listed |
| Dec 15, 2016 | Zimmer Biomet, Inc. Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265 Terminated |
JWH | None listed |
| Jun 11, 2015 | Biomet, Inc. MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM
Knee joint replacement prostheses components include femoral, tibial, and patellar components. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.