HSN
- Product code
- HSN
- Device name
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3110
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 14
- Summaries archived here
- 12 (direct download)
- 510(k) clearances (all years, FDA)
- 68 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253159 | 2026-06-16 | Wright Medical Technology, Inc. (Stryk… | Prophecy Incompass Surgical Planning System | FDA |
| K252454 | 2025-09-03 | Restor3D | Kinos Total Ankle System | |
| K250037 | 2025-06-20 | Wright Medical Technology, Inc. (Stryk… | Incompass Total Ankle System | |
| K250641 | 2025-05-01 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | |
| K240475 | 2024-12-02 | Vilex, LLC | Hintermann Series H2 Total Ankle System | |
| K241999 | 2024-11-01 | Wright Medical Technology, Inc. (Stryk… | Prophecy Surgical Planning System | |
| K242868 | 2024-10-18 | Restor3D | Kinos Total Ankle System | |
| K241482 | 2024-07-22 | Restor3D | Kinos Total Ankle System | |
| K240259 | 2024-06-24 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | |
| K240591 | 2024-04-29 | Restor3D, Inc. | restor3d Kinos Axiom Total Ankle System | FDA |
| K231699 | 2024-04-23 | In2bones Sas | QUANTUM® Patient Specific Instrumentation (PSI) Syst… | |
| K232595 | 2023-11-28 | Restor3D | Kinos Axiom Total Ankle System | |
| K230717 | 2023-10-12 | Exactech, Inc. | Exactech® Vantage® Total Ankle System | |
| K232002 | 2023-09-11 | Exactech, Inc. | Vantage® Total Ankle System |
Official FDA classification page: HSN
Classification and pathway per current FDA publications. Data from openFDA (CC0).