SURGICAL INSTRUMENTS, ORTHOPEDIC
FDA 510(k) clearance K760325 · decided 1976-08-03
Clearance details
- K-number
- K760325
- Device name
- SURGICAL INSTRUMENTS, ORTHOPEDIC
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-26
- Decision date
- 1976-08-03
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- HTX
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MANUAL RONGEUR (K874954) | Solway, Inc. | 1987-12-30 |
| FRONT RADIUS CUTTER (K841620) | Plastafil, Inc. | 1984-09-20 |
| BACK RADIUS CUTTER (K841621) | Plastafil, Inc. | 1984-09-20 |
| ORTHOPEDIC FORCEPS (K780397) | Orthopedic Equipment Co., Inc. | 1978-03-22 |
Recalls involving this device
No recalls on record reference this clearance.
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 |