FDA 510(k) Applications for Medical Device Product Code "HSN"
(Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K182878 | Ascension Orthopedics | Integra Salto Total Ankle System | 12/18/2018 |
| K151459 | Ascension Orthopedics | Integra Total Ankle Replacement System | 08/31/2015 |
| K053569 | DEPUY ORTHOPAEDICS, INC. | AGILITY LP TOTAL ANKLE PROSTHESIS | 03/31/2006 |
| K122395 | DEPUY ORTHOPAEDICS, INC. | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS | 10/31/2012 |
| K020541 | DEPUY, INC. | AGILITY ANKLE REVISION PROSTHESIS | 05/20/2002 |
| K171004 | Dt MedTech LLC | Hintermann Series H2 Total Ankle System | 11/07/2017 |
| K152217 | EXACTECH INC | Exactech Vantage Total Ankle System | 03/10/2016 |
| K183343 | Exactech Inc | Vantage Total Ankle Flat Cut Talar Components | 04/01/2019 |
| K232002 | Exactech Inc. | Vantage« Total Ankle System | 09/11/2023 |
| K230717 | Exactech, Inc. | Exactech« Vantage« Total Ankle System | 10/12/2023 |
| K230313 | In2Bones SAS | QUANTUM Patient Specific Instrumentation (PSI) System | 04/06/2023 |
| K211883 | In2Bones SAS | QUANTUM« Patient Specific Instrumentation (PSI) System | 08/11/2021 |
| K231699 | In2Bones SAS | QUANTUM« Patient Specific Instrumentation (PSI) System | 04/23/2024 |
| K191380 | In2Bones SAS | Quantum« Total Ankle Prosthesis | 01/29/2020 |
| K201507 | Integra Lifesciences Corporation | Cadence Total Ankle System | 06/29/2020 |
| K061749 | KINETIKOS MEDICAL, INC. | ECLIPSE TOTAL ANKLE IMPLANT | 11/22/2006 |
| K192778 | Kinos Medical | Kinos Axiom Total Ankle System | 06/30/2020 |
| K223227 | Paragon 28, Inc | MAVENÖ Patient-Specific Instrumentation | 11/17/2022 |
| K250641 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | 05/01/2025 |
| K202373 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | 11/13/2020 |
| K210390 | Paragon 28, Inc. | Apex 3D Total Ankle Replacement System | 03/06/2021 |
| K240259 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | 06/24/2024 |
| K202019 | Paragon 28, Inc. | Maven Patient-Specific Instrumentation | 01/14/2021 |
| K192994 | Paragon 28, Inc. | Paragon 28 APEX 3D Total Ankle Replacement System | 07/10/2020 |
| K232595 | restor3d | Kinos Axiom Total Ankle System | 11/28/2023 |
| K241482 | restor3d | Kinos Total Ankle System | 07/22/2024 |
| K242868 | restor3d | Kinos Total Ankle System | 10/18/2024 |
| K240591 | restor3d, Inc. | restor3d Kinos Axiom Total Ankle System | 04/29/2024 |
| K051023 | TOPEZ ORTHOPEDICS, INC | TOPEZ TOTAL ANKLE REPLACEMENT | 11/15/2005 |
| K090076 | TORNIER | SALTO TALARIS TOTAL ANKLE PROSTHESIS | 03/17/2009 |
| K060544 | TORNIER | SALTO TALARIS TOTAL ANKLE PROSTHESIS | 11/13/2006 |
| K130533 | Tornier SAS | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS | 05/17/2013 |
| K153452 | Tornier SAS | Salto XT, Salto Talaris | 08/11/2016 |
| K240475 | Vilex, LLC | Hintermann Series H2 Total Ankle System | 12/02/2024 |
| K230462 | Vilex, LLC | OPTIX H2 Patient Specific Instrument System | 07/17/2023 |
| K241999 | Wright Medical Technology, Inc (Stryker) | Prophecy Surgical Planning System | 11/01/2024 |
| K123059 | WRIGHT MEDICAL TECHNOLOGY, INC. | INBONE ( I AND II) TOTAL ANKLE SYSTEMS | 03/04/2013 |
| K100886 | WRIGHT MEDICAL TECHNOLOGY, INC. | INBONE II TOTAL ANKLE REPLACEMENT | 08/26/2010 |
| K133585 | WRIGHT MEDICAL TECHNOLOGY, INC. | INBONE TOTAL ANKLE | 02/20/2014 |
| K103374 | WRIGHT MEDICAL TECHNOLOGY, INC. | INBONE TOTAL ANKLE SYSTEM MODEL 200347902 | 12/14/2010 |
| K141740 | WRIGHT MEDICAL TECHNOLOGY, INC. | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | 03/05/2015 |
| K140749 | WRIGHT MEDICAL TECHNOLOGY, INC. | INFINITY TOTAL ANKLE SYSTEM | 04/25/2014 |
| K172633 | Wright Medical Technology, Inc. | INFINITY Total Ankle System | 04/26/2018 |
| K181557 | Wright Medical Technology, Inc. | INFINITY Total Ankle System | 08/09/2018 |
| K123954 | WRIGHT MEDICAL TECHNOLOGY, INC. | INFINITY TOTAL ANKLE SYSTEM | 04/01/2013 |
| K191393 | Wright Medical Technology, Inc. | INFINITY Total Ankle System, INBONE Total Ankle System | 08/22/2019 |
| K142117 | WRIGHT MEDICAL TECHNOLOGY, INC. | INVISION TOTAL ANKLE REVISION SYSTEM | 03/25/2015 |
| K153008 | Wright Medical Technology, Inc. | INVISION Total Ankle Revision System | 05/06/2016 |
| K171067 | Wright Medical Technology, Inc. | INVISION Total Ankle Revision System | 09/11/2017 |
| K180730 | Wright Medical Technology, Inc. | INVISION Total Ankle Revision System | 07/11/2018 |
| K110360 | WRIGHT MEDICAL TECHNOLOGY, INC. | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | 12/16/2011 |
| K131283 | WRIGHT MEDICAL TECHNOLOGY, INC. | PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES | 07/05/2013 |
| K170968 | Wright Medical Technology, Inc. | PROPHECY INVISION Pre-operative Navigation System | 08/16/2017 |
| K162795 | Wright Medical Technology, Inc. | PROPHECY INVISION Preoperative Navigation Alignment System | 02/22/2017 |
| K202815 | Wright Medical Technology, Inc. | PROPHECY Preoperative Navigation Alignment System | 03/10/2021 |
| K222835 | Wright Medical Technology, Inc. | Prophecy Preoperative Navigation Alignment System | 01/27/2023 |
| K193067 | Wright Medical Technology, Inc. | The INBONEÖ Total Ankle System, the INFINITYÖ Total Ankle System and the INVISIONÖ Total Ankle Revision System | 06/08/2020 |
| K250037 | Wright Medical Technology, Inc. (Stryker) | Incompass Total Ankle System | 06/20/2025 |
| K120906 | ZIMMER, INC. | ZIMMER TRABECULAR METAL TOTAL ANKLE | 08/24/2012 |
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