OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
FDA 510(k) clearance K863668 · decided 1986-12-19
Clearance details
- K-number
- K863668
- Device name
- OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
- Applicant
- Osteonics Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1986-09-18
- Decision date
- 1986-12-19
- Days to decision
- 92 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 RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 recall (Z-0869-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028 recall (Z-0870-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030 recall (Z-0871-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032 recall (Z-0872-2024) | Howmedica Osteonics Corp. | 2024-01-31 |