510(k) Report

Devices descending from K021306

387 later devices reach Vectorvision CT-Free Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+5K242569Mixed Reality Spine NavigationBrainlab AG20250—
+5K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+5K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+5K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+5K232140OTS HipOrtoma AB202421
+5K223351Naviswiss KneeNaviswiss AG20230—
+5K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+5K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K193618ExactechGPS SystemBlue Ortho202021
+5K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K182359HipCheckStryker Corp.20181—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+5K173946ADAPT for Gamma3Stryker GmbH20182—
+5K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+5K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+5K143668NavioBlue Belt Technologies, Inc.201520—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141601Iassist Knee SystemZimmer Cas20142—
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+5K120812RenaissanceMazor Robotics, Ltd.2012211
+5K113228Renaissance SystemMazor Robotics, Ltd.201123—
+5K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+6K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+6K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+6K250086OTS HipOrtoma AB202511
+6K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+6K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+6K230045HipCheckStryker Corp.20230—
+6K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+6K213877ExactechGPS® SystemBlue Ortho20221—
+6K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+6K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+6K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+6K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+6K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+6K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+6K152574NavioBlue Belt Technologies, Inc.201519—
+6K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+6K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+7K261852OTS HipOrtoma AB20260—
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K233299ExactechGPS® SystemBlue Ortho20240—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K203751OMNIVision systemCorin USA20210—
+7K203205Navigated Spine InstrumentsStryker Spine20218—
+7K202749ADAPT for Gamma3Stryker GmbH20200—
+7K200655FibroScan® 630Echosens20200—
+7K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+7K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—