510(k) K171054 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet Knee Joint Replacement Prostheses
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 28, 2017 |
| Received | Apr 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2018 | Zimmer Biomet, Inc. Vanguard Knee System Series-A Standard Patella sizes 34mm
Item Number: 184766 Terminated |
JWH | None listed |
| Jun 4, 2018 | Zimmer Biomet, Inc. Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642
Product Usage: The product is intended for use in knee joint replacement arthroplasties. Terminated |
JWH | None listed |
| Jun 1, 2018 | Zimmer Biomet, Inc. Vanguard Knee System PS Tibial Bearing, Part Number 183621
Intended for use in knee joint replacement procedures. Terminated |
JWH | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.