P.C.A.(TM) TOTAL KNEE SYSTEM
FDA premarket approval P840049 · decided 1988-09-30
Approval details
- PMA number
- P840049
- Trade name
- P.C.A.(TM) TOTAL KNEE SYSTEM
- Generic name
- PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
- Applicant
- Howmedica Corp.
- Date received
- 1984-10-09
- Decision date
- 1988-09-30
- Days to decision
- 1452 days
- Decision code
- APWD
- Product code
- HRY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Rutherford, NJ
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MICRO DYNAMIC MESH (K983528) | Howmedica Corp. | 1998-12-23 |
| TYPE 3 FEMORAL COMPONENTS (K983404) | Howmedica Corp. | 1998-12-22 |
| DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (K980926) | Howmedica Corp. | 1998-12-16 |
| DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (K980925) | Howmedica Corp. | 1998-12-16 |
| DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (K980632) | Howmedica Corp. | 1998-12-11 |
| DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (K980626) | Howmedica Corp. | 1998-12-11 |
| HOFFMANN II MIAMI POST (K983419) | Howmedica Corp. | 1998-11-25 |
| ZETA MULTIZONE LOCKING NAIL SYSTEM (K982958) | Howmedica Corp. | 1998-11-20 |