Product code HSN
- Device name
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3110
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2026-06-16 |
| K252454 | Kinos Total Ankle System | Restor3D | 2025-09-03 |
| K250037 | Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) | 2025-06-20 |
| K250641 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2025-05-01 |
| K240475 | Hintermann Series H2 Total Ankle System | Vilex, LLC | 2024-12-02 |
| K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2024-11-01 |
| K242868 | Kinos Total Ankle System | Restor3D | 2024-10-18 |
| K241482 | Kinos Total Ankle System | Restor3D | 2024-07-22 |
| K240259 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2024-06-24 |
| K240591 | restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. | 2024-04-29 |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2024-04-23 |
| K232595 | Kinos Axiom Total Ankle System | Restor3D | 2023-11-28 |
| K230717 | Exactech® Vantage® Total Ankle System | Exactech, Inc. | 2023-10-12 |
| K232002 | Vantage® Total Ankle System | Exactech, Inc. | 2023-09-11 |
| K230462 | OPTIX H2 Patient Specific Instrument System | Vilex, LLC | 2023-07-17 |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | In2bones Sas | 2023-04-06 |
| K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2023-01-27 |
| K223227 | MAVEN™ Patient-Specific Instrumentation | Paragon 28, Inc. | 2022-11-17 |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2021-08-11 |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021-03-10 |
| K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021-03-06 |
| K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021-01-14 |
| K202373 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-11-13 |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-07-10 |
| K192778 | Kinos Axiom Total Ankle System | Kinos Medical | 2020-06-30 |
| K201507 | Cadence Total Ankle System | Integra LifeSciences Corporation | 2020-06-29 |
| K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System | Wrightmedicaltechnologyinc | 2020-06-08 |
| K191380 | Quantum® Total Ankle Prosthesis | In2bones Sas | 2020-01-29 |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | 2019-08-22 |
| K183343 | Vantage Total Ankle Flat Cut Talar Components | Exactech, Inc. | 2019-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556832066 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832202 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832196 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832189 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832172 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832165 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832158 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832141 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832134 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832127 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832110 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832103 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832097 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832080 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832073 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831892 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832059 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832042 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832035 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832028 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832011 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556832004 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831991 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831984 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831977 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831960 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831953 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831946 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556831939 | Salto Talaris Total Ankle Prosthesis | Smith & Nephew, Inc. | 2022-12-21 |
| 00885556841419 | XT Revision Ankle Replacement System | Smith & Nephew, Inc. | 2022-12-21 |