510(k) K915512 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
| Applicant | Pfizer Hospital Products Group, Inc., Rutherford NJ, US |
| Decision | Substantially Equivalent for Some Indications, Aug 18, 1992 |
| Received | Dec 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915512
| 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 |
| Jul 7, 2009 | Stryker Howmedica Osteonics Corp. Duracon Total Knee, A-P Lipped Tibial Insert; 11MM
Sterile; Howmedica Osteonics Corp.
Stryker, Ireland. Product No. 6642-1-611.
The device is used to replace bearing surface if the proximal tibia in Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.