510(k) K032163 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
DURACON TOTAL KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 12, 2003 |
| Received | Jul 15, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. DURATION A-P LIPPED TIB.INSERT-DURAC
Intended for knee replacement
Product Number: 6642-1-709 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. DURATION A-P LIPPED TIB.INSERT-DURAC
Intended for knee replacement
Product Number: 6642-1-911 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. DURATION PLASTIC PATELLA-DURACON
Intended for knee replacement
Product Number: 6642-2-200 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.