Panels › Orthopedic › Product code HSN · Class 2
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation 888.3110
2510(k)s in 12 months (69 all time)
0recalls in 12 months (47 all time)
47recalls that name a 510(k)
Top companies in HSN
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 1 | 28 |
| Wrightmedicaltechnologyinc | 21 | 0 |
| Exactech, Inc. | 4 | 5 |
| Wright Medical Technology Inc | 0 | 9 |
| Paragon 28, Inc. | 8 | 0 |
| Restor3D | 5 | 0 |
| Depuy, Inc. | 4 | 0 |
| In2bones Sas | 4 | 0 |
| Zimmer, Inc. | 1 | 3 |
| Tornier | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 7, 2026 | K261120 | APEX 3D S Diamond Tibia Paragon 28, Inc. | HSN |
| Jun 16, 2026 | K253159 | Prophecy Incompass Surgical Planning System Wright Medical Technology, Inc. (Stryker) | HSN |
| Sep 3, 2025 | K252454 | Kinos Total Ankle System Restor3D | HSN |
| Jun 20, 2025 | K250037 | Incompass Total Ankle System Wright Medical Technology, Inc. (Stryker) | HSN |
| May 1, 2025 | K250641 | APEX 3D Total Ankle Replacement System Paragon 28, Inc. | HSN |
| Dec 2, 2024 | K240475 | Hintermann Series H2 Total Ankle System Vilex, LLC | HSN |
| Nov 1, 2024 | K241999 | Prophecy Surgical Planning System Wright Medical Technology, Inc. (Stryker) | HSN |
| Oct 18, 2024 | K242868 | Kinos Total Ankle System Restor3D | HSN |
| Jul 22, 2024 | K241482 | Kinos Total Ankle System Restor3D | HSN |
| Jun 24, 2024 | K240259 | APEX 3D Total Ankle Replacement System Paragon 28, Inc. | HSN |
| Apr 29, 2024 | K240591 | restor3d Kinos Axiom Total Ankle System Restor3D, Inc. | HSN |
| Apr 23, 2024 | K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System In2bones Sas, FR | HSN |
| Nov 28, 2023 | K232595 | Kinos Axiom Total Ankle System Restor3D | HSN |
| Oct 12, 2023 | K230717 | Exactech® Vantage® Total Ankle System Exactech, Inc. | HSN |
| Sep 11, 2023 | K232002 | Vantage® Total Ankle System Exactech, Inc. | HSN |
| Jul 17, 2023 | K230462 | OPTIX H2 Patient Specific Instrument System Vilex, LLC | HSN |
| Apr 6, 2023 | K230313 | QUANTUM Patient Specific Instrumentation (PSI) System In2bones Sas, FR | HSN |
| Jan 27, 2023 | K222835 | Prophecy Preoperative Navigation Alignment System Wrightmedicaltechnologyinc | HSN |
| Nov 17, 2022 | K223227 | MAVEN Patient-Specific Instrumentation Paragon 28, Inc. | HSN |
| Aug 11, 2021 | K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System In2bones Sas, FR | HSN |
| Mar 10, 2021 | K202815 | PROPHECY Preoperative Navigation Alignment System Wrightmedicaltechnologyinc | HSN |
| Mar 6, 2021 | K210390 | Apex 3D Total Ankle Replacement System Paragon 28, Inc. | HSN |
| Jan 14, 2021 | K202019 | Maven Patient-Specific Instrumentation Paragon 28, Inc. | HSN |
| Nov 13, 2020 | K202373 | APEX 3D Total Ankle Replacement System Paragon 28, Inc. | HSN |
| Jul 10, 2020 | K192994 | Paragon 28 APEX 3D Total Ankle Replacement System Paragon 28, Inc. | HSN |
| Jun 30, 2020 | K192778 | Kinos Axiom Total Ankle System Kinos Medical | HSN |
| Jun 29, 2020 | K201507 | Cadence Total Ankle System Integra LifeSciences Corporation | HSN |
| Jun 8, 2020 | K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Jan 29, 2020 | K191380 | Quantum® Total Ankle Prosthesis In2bones Sas, FR | HSN |
| Aug 22, 2019 | K191393 | INFINITY Total Ankle System, INBONE Total Ankle System Wrightmedicaltechnologyinc | HSN |
| Apr 1, 2019 | K183343 | Vantage Total Ankle Flat Cut Talar Components Exactech, Inc. | HSN |
| Dec 18, 2018 | K182878 | Integra Salto Total Ankle System Ascension Orthopedics | HSN |
| Aug 9, 2018 | K181557 | INFINITY Total Ankle System Wrightmedicaltechnologyinc | HSN |
| Jul 11, 2018 | K180730 | INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Apr 26, 2018 | K172633 | INFINITY Total Ankle System Wrightmedicaltechnologyinc | HSN |
| Nov 7, 2017 | K171004 | Hintermann Series H2 Total Ankle System Dt Medtech, LLC | HSN |
| Sep 11, 2017 | K171067 | INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Aug 16, 2017 | K170968 | PROPHECY INVISION Pre-operative Navigation System Wrightmedicaltechnologyinc | HSN |
| Feb 22, 2017 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System Wrightmedicaltechnologyinc | HSN |
| Aug 11, 2016 | K153452 | Salto XT, Salto Talaris Tornier S.A.S., FR | HSN |
| May 6, 2016 | K153008 | INVISION Total Ankle Revision System Wrightmedicaltechnologyinc | HSN |
| Mar 10, 2016 | K152217 | Exactech Vantage Total Ankle System Exactech, Inc. | HSN |
| Aug 31, 2015 | K151459 | Integra Total Ankle Replacement System Ascension Orthopedics | HSN |
| Mar 25, 2015 | K142117 | INVISION TOTAL ANKLE REVISION SYSTEM Wrightmedicaltechnologyinc | HSN |
| Mar 5, 2015 | K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc | HSN |
| Apr 25, 2014 | K140749 | INFINITY TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc | HSN |
| Feb 20, 2014 | K133585 | INBONE TOTAL ANKLE Wrightmedicaltechnologyinc | HSN |
| Jul 5, 2013 | K131283 | PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES Wrightmedicaltechnologyinc | HSN |
| May 17, 2013 | K130533 | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS Tornier S.A.S., FR | HSN |
| Apr 1, 2013 | K123954 | INFINITY TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc | HSN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.