510(k) K013031 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
MOST OPTIONS SYSTEM
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Dec 7, 2001 |
| Received | Sep 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2014 | Zimmer, Inc. MOST Options" System (MOST)
HINGED TIB INS SZ 1 16MM
HINGED TIB INS SZ 4 6MM M
HINGED TIB INS SZ 4 9MM M
HINGED TIB INS SZ 4 16MM
MOST PROX TIB INS 6MM Terminated |
KRO | None listed |
| Mar 9, 2009 | Zimmer Inc. Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001.
Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V A Terminated |
KRO | None listed |
| Feb 15, 2005 | Zimmer Austin, Inc MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717 Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.