ALVINE TOTAL ANKLE
FDA 510(k) clearance K920802 · decided 1992-12-17
Clearance details
- K-number
- K920802
- Device name
- ALVINE TOTAL ANKLE
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1992-02-21
- Decision date
- 1992-12-17
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- HSN
- Device class
- 2
- Regulation number
- 888.3110
- 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 |
|---|---|---|
| Prophecy Incompass Surgical Planning System (K253159) | Wright Medical Technology, Inc. (Stryker) | 2026-06-16 |
| Kinos Total Ankle System (K252454) | Restor3D | 2025-09-03 |
| Incompass Total Ankle System (K250037) | Wright Medical Technology, Inc. (Stryker) | 2025-06-20 |
| APEX 3D Total Ankle Replacement System (K250641) | Paragon 28, Inc. | 2025-05-01 |
| Hintermann Series H2 Total Ankle System (K240475) | Vilex, LLC | 2024-12-02 |
| Prophecy Surgical Planning System (K241999) | Wright Medical Technology, Inc. (Stryker) | 2024-11-01 |
| Kinos Total Ankle System (K242868) | Restor3D | 2024-10-18 |
| Kinos Total Ankle System (K241482) | Restor3D | 2024-07-22 |
| APEX 3D Total Ankle Replacement System (K240259) | Paragon 28, Inc. | 2024-06-24 |
| restor3d Kinos Axiom Total Ankle System (K240591) | Restor3D, Inc. | 2024-04-29 |
| QUANTUM® Patient Specific Instrumentation (PSI) System (K231699) | In2bones Sas | 2024-04-23 |
| Kinos Axiom Total Ankle System (K232595) | Restor3D | 2023-11-28 |
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 |