510(k) K921182 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 23, 1993 |
| Received | Mar 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2020 | Biomet, Inc. Knee Products:
155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM
155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM
155330 Knees AGC Knee System PS Molded Tibi Terminated |
JWH | None listed |
| Oct 31, 2007 | Biomet, Inc. Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthope Terminated |
JWH | None listed |
| Oct 31, 2007 | Biomet, Inc. Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.