SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
FDA 510(k) clearance K851341 · decided 1985-07-15
Clearance details
- K-number
- K851341
- Device name
- SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-03
- Decision date
- 1985-07-15
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- KYK
- Device class
- 2
- Regulation number
- 888.3500
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, 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 |
|---|---|---|
| MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM (K880826) | Johnson & Johnson Professionals, Inc. | 1988-03-14 |
| MODIFIED TOWNLEY UNICONDYLAR KNEE (K871118) | Depuy, Inc. | 1987-04-06 |
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 |