DEPUY AE TK2 HIP SCREW SYSTEM
FDA 510(k) clearance K972629 · decided 1997-10-09
Clearance details
- K-number
- K972629
- Device name
- DEPUY AE TK2 HIP SCREW SYSTEM
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-14
- Decision date
- 1997-10-09
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, steri recall (Z-0434-2008) | Depuy Orthopaedics, Inc. | 2008-01-24 |
| Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; R recall (Z-0435-2008) | Depuy Orthopaedics, Inc. | 2008-01-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |