510(k) Report

Devices descending from K920802

68 later devices reach Alvine Total Ankle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.20131619
+1K120906Zimmer Trabecular Metal Total AnkleZimmer, Inc.201214
+1K090076Salto Talaris Total Ankle ProsthesisTornier20092118
+1K060544Salto Talaris Total Ankle ProsthesisTornier20062318
+1K053569Agility LP Total Ankle ProsthesisDePuy Orthopaedics, Inc.200653—
+1K020541Agility Ankle Revision ProsthesisDepuy, Inc.200266—
+2K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+2K191380Quantum® Total Ankle ProsthesisIn2bones Sas20200—
+2K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+2K153452Salto XT, Salto TalarisTornier S.A.S.2016158
+2K152217Exactech Vantage Total Ankle SystemExactech, Inc.201676
+2K123954Infinity Total Ankle SystemWrightmedicaltechnologyinc2013522
+2K061749Eclipse Total Ankle ImplantKinetikos Medical, Inc.20060—
+2K051023Topez Total Ankle ReplacementTopez Orthopedics, Inc.2005644
+3K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+3K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.20240—
+3K230717Exactech® Vantage® Total Ankle SystemExactech, Inc.20230—
+3K232002Vantage® Total Ankle SystemExactech, Inc.20230—
+3K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+3K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+3K192778Kinos Axiom Total Ankle SystemKinos Medical20205—
+3K183343Vantage Total Ankle Flat Cut Talar ComponentsExactech, Inc.20190—
+3K182878Integra Salto Total Ankle SystemAscension Orthopedics201818
+3K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+3K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+3K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc201629—
+3K142117Invision Total Ankle Revision SystemWrightmedicaltechnologyinc201529—
+3K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc201517—
+3K140749Infinity Total Ankle SystemWrightmedicaltechnologyinc2014481
+3K133585Inbone Total AnkleWrightmedicaltechnologyinc201434—
+3K131283Prophecy Infinity Preoperative Navigation Alignment GuidesWrightmedicaltechnologyinc201318—
+3K123059Inbone ( I and II) Total Ankle SystemsWrightmedicaltechnologyinc201321—
+3K110360Prophecy Inbone Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc201119—
+3K100886Inbone II Total Ankle ReplacementWrightmedicaltechnologyinc2010562
+4K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)20260—
+4K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+4K232595Kinos Axiom Total Ankle SystemRestor3D20233—
+4K223326Axiom PSR SystemRestor3D202301
+4K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc20213—
+4K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.20212—
+4K202019Maven Patient-Specific InstrumentationParagon 28, Inc.20211—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K193067The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total…Wrightmedicaltechnologyinc20202—
+4K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+4K180730INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc20183—
+4K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc201713—
+4K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc201716—
+4K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc201717—
+4K151459Integra Total Ankle Replacement SystemAscension Orthopedics2015142
+5K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)20251—
+5K241482Kinos Total Ankle SystemRestor3D20242—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc20232—
+5K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+5K211883QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas20212—
+5K193432Vantage PSI System3D Systems20206—
+5K201507Cadence Total Ankle SystemIntegra LifeSciences Corporation20200—
+6K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)20241—
+6K242868Kinos Total Ankle SystemRestor3D20241—
+6K241326Cadence Ankle PSI System3D Systems, Inc.20241—
+6K241148Salto Talaris Ankle PSI System3D Systems, Inc.20241—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas20240—
+6K231585Vantage PSI System3D Systems, Inc.20230—
+6K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas20230—
+7K252454Kinos Total Ankle SystemRestor3D20250—
+7K243173Salto Talaris Ankle PSI System3D Systems, Inc.20240—
+7K243174Cadence Ankle PSI System3D Systems, Inc.20240—