FDA Product Code
FDA Product Code HSN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3110
510(k) Clearances — 68 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2026-06-16 | Traditional | PDF ↗ |
| K252454 | Kinos Total Ankle System | Restor3D | 2025-09-03 | Special | PDF ↗ |
| K250037 | Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) | 2025-06-20 | Traditional | PDF ↗ |
| K250641 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2025-05-01 | Traditional | PDF ↗ |
| K240475 | Hintermann Series H2 Total Ankle System | Vilex, LLC | 2024-12-02 | Traditional | PDF ↗ |
| K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2024-11-01 | Traditional | PDF ↗ |
| K242868 | Kinos Total Ankle System | Restor3D | 2024-10-18 | Special | PDF ↗ |
| K241482 | Kinos Total Ankle System | Restor3D | 2024-07-22 | Traditional | PDF ↗ |
| K240259 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2024-06-24 | Traditional | PDF ↗ |
| K240591 | restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. | 2024-04-29 | Traditional | PDF ↗ |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2024-04-23 | Traditional | PDF ↗ |
| K232595 | Kinos Axiom Total Ankle System | Restor3D | 2023-11-28 | Traditional | PDF ↗ |
| K230717 | Exactech® Vantage® Total Ankle System | Exactech, Inc. | 2023-10-12 | Traditional | PDF ↗ |
| K232002 | Vantage® Total Ankle System | Exactech, Inc. | 2023-09-11 | Traditional | PDF ↗ |
| K230462 | OPTIX H2 Patient Specific Instrument System | Vilex, LLC | 2023-07-17 | Traditional | PDF ↗ |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | In2bones Sas | 2023-04-06 | Traditional | PDF ↗ |
| K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2023-01-27 | Traditional | PDF ↗ |
| K223227 | MAVEN Patient-Specific Instrumentation | Paragon 28, Inc. | 2022-11-17 | Special | PDF ↗ |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2021-08-11 | Traditional | PDF ↗ |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021-03-10 | Traditional | PDF ↗ |
| K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021-03-06 | Special | PDF ↗ |
| K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021-01-14 | Traditional | PDF ↗ |
| K202373 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-11-13 | Traditional | PDF ↗ |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K192778 | Kinos Axiom Total Ankle System | Kinos Medical | 2020-06-30 | Traditional | PDF ↗ |
| K201507 | Cadence Total Ankle System | Integra LifeSciences Corporation | 2020-06-29 | Special | PDF ↗ |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2020-06-08 | Traditional | PDF ↗ |
| K191380 | Quantum® Total Ankle Prosthesis | In2bones Sas | 2020-01-29 | Traditional | PDF ↗ |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | 2019-08-22 | Traditional | PDF ↗ |
| K183343 | Vantage Total Ankle Flat Cut Talar Components | Exactech, Inc. | 2019-04-01 | Traditional | PDF ↗ |
| K182878 | Integra Salto Total Ankle System | Ascension Orthopedics | 2018-12-18 | Special | PDF ↗ |
| K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018-08-09 | Traditional | PDF ↗ |
| K180730 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2018-07-11 | Traditional | PDF ↗ |
| K172633 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018-04-26 | Traditional | PDF ↗ |
| K171004 | Hintermann Series H2 Total Ankle System | Dt Medtech, LLC | 2017-11-07 | Traditional | PDF ↗ |
| K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017-09-11 | Traditional | PDF ↗ |
| K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017-08-16 | Traditional | PDF ↗ |
| K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017-02-22 | Traditional | PDF ↗ |
| K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016-08-11 | Traditional | PDF ↗ |
| K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016-05-06 | Traditional | PDF ↗ |
| K152217 | Exactech Vantage Total Ankle System | Exactech, Inc. | 2016-03-10 | Traditional | PDF ↗ |
| K151459 | Integra Total Ankle Replacement System | Ascension Orthopedics | 2015-08-31 | Traditional | PDF ↗ |
| K142117 | INVISION TOTAL ANKLE REVISION SYSTEM | Wrightmedicaltechnologyinc | 2015-03-25 | Traditional | PDF ↗ |
| K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2015-03-05 | Traditional | PDF ↗ |
| K140749 | INFINITY TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2014-04-25 | Special | PDF ↗ |
| K133585 | INBONE TOTAL ANKLE | Wrightmedicaltechnologyinc | 2014-02-20 | Special | PDF ↗ |
| K131283 | PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES | Wrightmedicaltechnologyinc | 2013-07-05 | Traditional | PDF ↗ |
| K130533 | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS | Tornier S.A.S. | 2013-05-17 | Special | PDF ↗ |
| K123954 | INFINITY TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2013-04-01 | Traditional | PDF ↗ |
| K123059 | INBONE ( I AND II) TOTAL ANKLE SYSTEMS | Wrightmedicaltechnologyinc | 2013-03-04 | Traditional | PDF ↗ |
| K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS | DePuy Orthopaedics, Inc. | 2012-10-31 | Special | PDF ↗ |
| K120906 | ZIMMER TRABECULAR METAL TOTAL ANKLE | Zimmer, Inc. | 2012-08-24 | Traditional | PDF ↗ |
| K110360 | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | Wrightmedicaltechnologyinc | 2011-12-16 | Traditional | PDF ↗ |
| K103374 | INBONE TOTAL ANKLE SYSTEM MODEL 200347902 | Wrightmedicaltechnologyinc | 2010-12-14 | Special | PDF ↗ |
| K100886 | INBONE II TOTAL ANKLE REPLACEMENT | Wrightmedicaltechnologyinc | 2010-08-26 | Traditional | PDF ↗ |
| K090076 | SALTO TALARIS TOTAL ANKLE PROSTHESIS | Tornier | 2009-03-17 | Special | PDF ↗ |
| K061749 | ECLIPSE TOTAL ANKLE IMPLANT | Kinetikos Medical, Inc. | 2006-11-22 | Traditional | PDF ↗ |
| K060544 | SALTO TALARIS TOTAL ANKLE PROSTHESIS | Tornier | 2006-11-13 | Traditional | PDF ↗ |
| K053569 | AGILITY LP TOTAL ANKLE PROSTHESIS | DePuy Orthopaedics, Inc. | 2006-03-31 | Special | PDF ↗ |
| K051023 | TOPEZ TOTAL ANKLE REPLACEMENT | Topez Orthopedics, Inc. | 2005-11-15 | Traditional | PDF ↗ |
| K020541 | AGILITY ANKLE REVISION PROSTHESIS | Depuy, Inc. | 2002-05-20 | Traditional | PDF ↗ |
| K920802 | ALVINE TOTAL ANKLE | Depuy, Inc. | 1992-12-17 | Traditional | PDF ↗ |
| K803167 | BRIGHAM TOTAL ANKLE PROSTHESIS | Howmedica Corp. | 1981-02-19 | Traditional | PDF ↗ |
| K800530 | SCHLEIN TRI-SURFACE ANKLE | Orthopedic Equipment Co., Inc. | 1980-04-02 | Traditional | PDF ↗ |
| K770421 | COMPONENTS, ANKLE, TRIAL, CON-AXIAL | Depuy, Inc. | 1977-03-14 | Traditional | PDF ↗ |
| K770420 | FORCEPS, ANKLE INSERTING, CON-AXIAL | Depuy, Inc. | 1977-03-14 | Traditional | PDF ↗ |
| K761021 | ANKLE INSTRUMENTS (FREEMAN-SWANSON) | Medishield, Inc. | 1976-11-23 | Traditional | PDF ↗ |
| K761020 | ANKLE (FREEMAN-SWANSON) | Medishield, Inc. | 1976-11-23 | Traditional | PDF ↗ |
Product code HSN · Class II · Orthopedic. Data: openFDA.