TOPEZ TOTAL ANKLE REPLACEMENT
FDA 510(k) clearance K051023 · decided 2005-11-15
Clearance details
- K-number
- K051023
- Device name
- TOPEZ TOTAL ANKLE REPLACEMENT
- Applicant
- Topez Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-22
- Decision date
- 2005-11-15
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- HSN
- Device class
- 2
- Regulation number
- 888.3110
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Topez Orthopedics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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
| Record | Firm | Date |
|---|---|---|
| Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 20 recall (Z-0139-2023) | Wright Medical Technology, Inc. | 2022-10-27 |
| Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 20 recall (Z-0140-2023) | Wright Medical Technology, Inc. | 2022-10-27 |