510(k) K093293 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
VANGUARD 360 REVISION KNEE SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 22, 2010 |
| Received | Oct 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2020 | Biomet, Inc. Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty
Item Number: 185422 Terminated |
JWH | None listed |
| Aug 2, 2018 | Zimmer Biomet, Inc. Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221
Intended for use in Total Knee Arthroplasty Terminated |
JWH | None listed |
| Aug 2, 2018 | Zimmer Biomet, Inc. Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224
Intended for use in Total Knee Arthroplasty Terminated |
JWH | None listed |
| Oct 3, 2016 | Zimmer Biomet, Inc. Vanguard 360 Revision Knee System
Knee prostheses Terminated |
JWH | None listed |
| Aug 15, 2014 | Biomet, Inc. Vanguard 360 Femoral Boss Reamer,
Label: REF 32-488474
VANGUARD 360 1NSTRUMENT
FEMORAL BOSS REAMER
NON-STERILE,
BIOMET ORTHOPEDICS
56 EAST BELL DRIVE
P.O. BOX 587 WARSAW, IN 46581 USA Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.