OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT
FDA 510(k) clearance K972967 · decided 1998-01-16
Clearance details
- K-number
- K972967
- Device name
- OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1997-08-11
- Decision date
- 1998-01-16
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110 recall (Z-0893-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308 recall (Z-0894-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508 recall (Z-0895-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708 recall (Z-0896-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710 recall (Z-0897-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910 recall (Z-0900-2024) | Howmedica Osteonics Corp. | 2024-01-31 |