Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HSN — Predicate Candidate Screening
68 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
259 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253159 | Prophecy Incompass Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2026-06-16 | 263 | 0 |
| K252454 | Kinos Total Ankle System | Restor3D | 2025-09-03 | 30 | 0 |
| K250037 | Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) | 2025-06-20 | 163 | 0 |
| K250641 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2025-05-01 | 58 | 0 |
| K240475 | Hintermann Series H2 Total Ankle System | Vilex, LLC | 2024-12-02 | 286 | 0 |
| K241999 | Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) | 2024-11-01 | 115 | 0 |
| K242868 | Kinos Total Ankle System | Restor3D | 2024-10-18 | 28 | 0 |
| K241482 | Kinos Total Ankle System | Restor3D | 2024-07-22 | 59 | 0 |
| K240259 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2024-06-24 | 145 | 0 |
| K240591 | restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. | 2024-04-29 | 59 | 0 |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2024-04-23 | 316 | 0 |
| K232595 | Kinos Axiom Total Ankle System | Restor3D | 2023-11-28 | 95 | 0 |
| K230717 | Exactech® Vantage® Total Ankle System | Exactech, Inc. | 2023-10-12 | 211 | 0 |
| K232002 | Vantage® Total Ankle System | Exactech, Inc. | 2023-09-11 | 68 | 0 |
| K230462 | OPTIX H2 Patient Specific Instrument System | Vilex, LLC | 2023-07-17 | 146 | 0 |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | In2bones Sas | 2023-04-06 | 59 | 0 |
| K222835 | Prophecy Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2023-01-27 | 129 | 0 |
| K223227 | MAVEN™ Patient-Specific Instrumentation | Paragon 28, Inc. | 2022-11-17 | 30 | 0 |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | 2021-08-11 | 51 | 0 |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2021-03-10 | 167 | 0 |
| K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | 2021-03-06 | 25 | 0 |
| K202019 | Maven Patient-Specific Instrumentation | Paragon 28, Inc. | 2021-01-14 | 177 | 0 |
| K202373 | APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-11-13 | 86 | 0 |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020-07-10 | 259 | 0 |
| K192778 | Kinos Axiom Total Ankle System | Kinos Medical | 2020-06-30 | 274 | 0 |
| K201507 | Cadence Total Ankle System | Integra LifeSciences Corporation | 2020-06-29 | 24 | 0 |
| K193067 | The INBONE™ Total Ankle System, the INFINITY™ Total Ankle Sy | Wrightmedicaltechnologyinc | 2020-06-08 | 217 | 0 |
| K191380 | Quantum® Total Ankle Prosthesis | In2bones Sas | 2020-01-29 | 251 | 0 |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | 2019-08-22 | 90 | 0 |
| K183343 | Vantage Total Ankle Flat Cut Talar Components | Exactech, Inc. | 2019-04-01 | 119 | 0 |
| K182878 | Integra Salto Total Ankle System | Ascension Orthopedics | 2018-12-18 | 64 | 0 |
| K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018-08-09 | 57 | 0 |
| K180730 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2018-07-11 | 113 | 0 |
| K172633 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018-04-26 | 237 | 0 |
| K171004 | Hintermann Series H2 Total Ankle System | Dt Medtech, LLC | 2017-11-07 | 217 | 0 |
| K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2017-09-11 | 154 | 0 |
| K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | 2017-08-16 | 138 | 0 |
| K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | 2017-02-22 | 141 | 0 |
| K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | 2016-08-11 | 255 | 0 |
| K153008 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | 2016-05-06 | 205 | 0 |
| K152217 | Exactech Vantage Total Ankle System | Exactech, Inc. | 2016-03-10 | 216 | 2 |
| K151459 | Integra Total Ankle Replacement System | Ascension Orthopedics | 2015-08-31 | 91 | 1 |
| K142117 | INVISION TOTAL ANKLE REVISION SYSTEM | Wrightmedicaltechnologyinc | 2015-03-25 | 233 | 0 |
| K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2015-03-05 | 251 | 0 |
| K140749 | INFINITY TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2014-04-25 | 31 | 0 |
| K133585 | INBONE TOTAL ANKLE | Wrightmedicaltechnologyinc | 2014-02-20 | 91 | 0 |
| K131283 | PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES | Wrightmedicaltechnologyinc | 2013-07-05 | 60 | 0 |
| K130533 | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS | Tornier S.A.S. | 2013-05-17 | 77 | 1 |
| K123954 | INFINITY TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2013-04-01 | 101 | 2 |
| K123059 | INBONE ( I AND II) TOTAL ANKLE SYSTEMS | Wrightmedicaltechnologyinc | 2013-03-04 | 154 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda