510(k) K940861 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent, Sep 18, 1995 |
| Received | Feb 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement
Part Number: 6637-0-228 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement
Part Number: 6637-0-231 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0-328 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0-631 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-0-831 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-0-928 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0-931 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.