DURATION STABILIZED UHMWPE KNEE COMPONENTS
FDA 510(k) clearance K972863 · decided 1997-10-29
Clearance details
- K-number
- K972863
- Device name
- DURATION STABILIZED UHMWPE KNEE COMPONENTS
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-04
- Decision date
- 1997-10-29
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609 recall (Z-0919-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611 recall (Z-0920-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709 recall (Z-0921-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
| DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711 recall (Z-0922-2024) | Howmedica Osteonics Corp. | 2024-01-31 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |