Atlas FDA

HSN

68 FDA 510(k) clearances · Product code

115 daysmedian time to decision
259 days90th percentile
68clearances measured

FDA profile

Official device name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3110
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 237 · 2022: 453 · 2023: 796 · 2024: 1,095 · 2025: 1,664 · 2026: 851
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Prophecy Incompass Surgical Planning System (K253159)Wright Medical Technology, Inc. (Stryker)2026-06-16
Kinos Total Ankle System (K252454)Restor3D2025-09-03
Incompass Total Ankle System (K250037)Wright Medical Technology, Inc. (Stryker)2025-06-20
APEX 3D Total Ankle Replacement System (K250641)Paragon 28, Inc.2025-05-01
Hintermann Series H2 Total Ankle System (K240475)Vilex, LLC2024-12-02
Prophecy Surgical Planning System (K241999)Wright Medical Technology, Inc. (Stryker)2024-11-01
Kinos Total Ankle System (K242868)Restor3D2024-10-18
Kinos Total Ankle System (K241482)Restor3D2024-07-22
APEX 3D Total Ankle Replacement System (K240259)Paragon 28, Inc.2024-06-24
restor3d Kinos Axiom Total Ankle System (K240591)Restor3D, Inc.2024-04-29
QUANTUM® Patient Specific Instrumentation (PSI) System (K231699)In2bones Sas2024-04-23
Kinos Axiom Total Ankle System (K232595)Restor3D2023-11-28
Exactech® Vantage® Total Ankle System (K230717)Exactech, Inc.2023-10-12
Vantage® Total Ankle System (K232002)Exactech, Inc.2023-09-11
OPTIX H2 Patient Specific Instrument System (K230462)Vilex, LLC2023-07-17
QUANTUM Patient Specific Instrumentation (PSI) System (K230313)In2bones Sas2023-04-06
Prophecy Preoperative Navigation Alignment System (K222835)Wrightmedicaltechnologyinc2023-01-27
MAVEN™ Patient-Specific Instrumentation (K223227)Paragon 28, Inc.2022-11-17
QUANTUM® Patient Specific Instrumentation (PSI) System (K211883)In2bones Sas2021-08-11
PROPHECY Preoperative Navigation Alignment System (K202815)Wrightmedicaltechnologyinc2021-03-10
Apex 3D Total Ankle Replacement System (K210390)Paragon 28, Inc.2021-03-06
Maven Patient-Specific Instrumentation (K202019)Paragon 28, Inc.2021-01-14
APEX 3D Total Ankle Replacement System (K202373)Paragon 28, Inc.2020-11-13
Paragon 28 APEX 3D Total Ankle Replacement System (K192994)Paragon 28, Inc.2020-07-10
Kinos Axiom Total Ankle System (K192778)Kinos Medical2020-06-30
Cadence Total Ankle System (K201507)Integra LifeSciences Corporation2020-06-29
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System (K193067)Wrightmedicaltechnologyinc2020-06-08
Quantum® Total Ankle Prosthesis (K191380)In2bones Sas2020-01-29
INFINITY Total Ankle System, INBONE Total Ankle System (K191393)Wrightmedicaltechnologyinc2019-08-22
Vantage Total Ankle Flat Cut Talar Components (K183343)Exactech, Inc.2019-04-01
Integra Salto Total Ankle System (K182878)Ascension Orthopedics2018-12-18
INFINITY Total Ankle System (K181557)Wrightmedicaltechnologyinc2018-08-09
INVISION Total Ankle Revision System (K180730)Wrightmedicaltechnologyinc2018-07-11
INFINITY Total Ankle System (K172633)Wrightmedicaltechnologyinc2018-04-26
Hintermann Series H2 Total Ankle System (K171004)Dt Medtech, LLC2017-11-07
INVISION Total Ankle Revision System (K171067)Wrightmedicaltechnologyinc2017-09-11
PROPHECY INVISION Pre-operative Navigation System (K170968)Wrightmedicaltechnologyinc2017-08-16
PROPHECY INVISION Preoperative Navigation Alignment System (K162795)Wrightmedicaltechnologyinc2017-02-22
Salto XT, Salto Talaris (K153452)Tornier S.A.S.2016-08-11
INVISION Total Ankle Revision System (K153008)Wrightmedicaltechnologyinc2016-05-06
Exactech Vantage Total Ankle System (K152217)Exactech, Inc.2016-03-10
Integra Total Ankle Replacement System (K151459)Ascension Orthopedics2015-08-31
INVISION TOTAL ANKLE REVISION SYSTEM (K142117)Wrightmedicaltechnologyinc2015-03-25
INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM (K141740)Wrightmedicaltechnologyinc2015-03-05
INFINITY TOTAL ANKLE SYSTEM (K140749)Wrightmedicaltechnologyinc2014-04-25
INBONE TOTAL ANKLE (K133585)Wrightmedicaltechnologyinc2014-02-20
PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES (K131283)Wrightmedicaltechnologyinc2013-07-05
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS (K130533)Tornier S.A.S.2013-05-17
INFINITY TOTAL ANKLE SYSTEM (K123954)Wrightmedicaltechnologyinc2013-04-01
INBONE ( I AND II) TOTAL ANKLE SYSTEMS (K123059)Wrightmedicaltechnologyinc2013-03-04
DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS (K122395)DePuy Orthopaedics, Inc.2012-10-31
ZIMMER TRABECULAR METAL TOTAL ANKLE (K120906)Zimmer, Inc.2012-08-24
PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES (K110360)Wrightmedicaltechnologyinc2011-12-16
INBONE TOTAL ANKLE SYSTEM MODEL 200347902 (K103374)Wrightmedicaltechnologyinc2010-12-14
INBONE II TOTAL ANKLE REPLACEMENT (K100886)Wrightmedicaltechnologyinc2010-08-26
SALTO TALARIS TOTAL ANKLE PROSTHESIS (K090076)Tornier2009-03-17
ECLIPSE TOTAL ANKLE IMPLANT (K061749)Kinetikos Medical, Inc.2006-11-22
SALTO TALARIS TOTAL ANKLE PROSTHESIS (K060544)Tornier2006-11-13
AGILITY LP TOTAL ANKLE PROSTHESIS (K053569)DePuy Orthopaedics, Inc.2006-03-31
TOPEZ TOTAL ANKLE REPLACEMENT (K051023)Topez Orthopedics, Inc.2005-11-15
AGILITY ANKLE REVISION PROSTHESIS (K020541)Depuy, Inc.2002-05-20
ALVINE TOTAL ANKLE (K920802)Depuy, Inc.1992-12-17
BRIGHAM TOTAL ANKLE PROSTHESIS (K803167)Howmedica Corp.1981-02-19
SCHLEIN TRI-SURFACE ANKLE (K800530)Orthopedic Equipment Co., Inc.1980-04-02
FORCEPS, ANKLE INSERTING, CON-AXIAL (K770420)Depuy, Inc.1977-03-14
COMPONENTS, ANKLE, TRIAL, CON-AXIAL (K770421)Depuy, Inc.1977-03-14
ANKLE INSTRUMENTS (FREEMAN-SWANSON) (K761021)Medishield, Inc.1976-11-23
ANKLE (FREEMAN-SWANSON) (K761020)Medishield, Inc.1976-11-23

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Every clearance here is in the API, with alerts when new ones post.