HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class II
FDA product code HSN covers "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3110. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HSN
- Device Class
- Class II
- Regulation Number
- 888.3110
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253159 | wright medical technology, inc. (stryker) | Prophecy Incompass Surgical Planning System | June 16, 2026 |
| K252454 | restor3d | Kinos Total Ankle System | September 3, 2025 |
| K250037 | wright medical technology, inc. (stryker) | Incompass Total Ankle System | June 20, 2025 |
| K250641 | paragon 28 | APEX 3D Total Ankle Replacement System | May 1, 2025 |
| K240475 | vilex | Hintermann Series H2 Total Ankle System | December 2, 2024 |
| K241999 | wright medical technology, inc. (stryker) | Prophecy Surgical Planning System | November 1, 2024 |
| K242868 | restor3d | Kinos Total Ankle System | October 18, 2024 |
| K241482 | restor3d | Kinos Total Ankle System | July 22, 2024 |
| K240259 | paragon 28 | APEX 3D Total Ankle Replacement System | June 24, 2024 |
| K240591 | restor3d | restor3d Kinos Axiom Total Ankle System | April 29, 2024 |
| K231699 | in2bones | QUANTUM® Patient Specific Instrumentation (PSI) System | April 23, 2024 |
| K232595 | restor3d | Kinos Axiom Total Ankle System | November 28, 2023 |
| K230717 | exactech | Exactech® Vantage® Total Ankle System | October 12, 2023 |
| K232002 | exactech | Vantage® Total Ankle System | September 11, 2023 |
| K230462 | vilex | OPTIX H2 Patient Specific Instrument System | July 17, 2023 |
| K230313 | in2bones | QUANTUM Patient Specific Instrumentation (PSI) System | April 6, 2023 |
| K222835 | wrightmedicaltechnologyinc | Prophecy Preoperative Navigation Alignment System | January 27, 2023 |
| K223227 | paragon 28 | MAVEN Patient-Specific Instrumentation | November 17, 2022 |
| K211883 | in2bones | QUANTUM® Patient Specific Instrumentation (PSI) System | August 11, 2021 |
| K202815 | wrightmedicaltechnologyinc | PROPHECY Preoperative Navigation Alignment System | March 10, 2021 |