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 |
|---|---|---|---|
| K261120 | APEX 3D S Diamond Tibia | Paragon 28, Inc. | 2026-10-07 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00889795151094 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151230 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151223 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151216 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151209 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151193 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151186 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151179 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151162 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151155 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151148 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151131 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151124 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151117 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151100 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150080 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151087 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151070 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151063 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151056 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151049 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151032 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151025 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151018 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795151001 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150134 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150127 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150110 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150103 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |
| 00889795150097 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2026-10-12 |