510(k) K972967 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent for Some Indications, Jan 16, 1998 |
| Received | Aug 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3110 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3308 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3508 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3708 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3710 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0910 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.