510(k) Report

Devices descending from K010612

838 later devices reach Vectorvision Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K143668NavioBlue Belt Technologies, Inc.201520—
+6K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+6K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+6K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+6K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+6K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+6K141137Stereos WorkstationEos Imaging20149—
+6K142077MylabgammaEsaote, S.p.A.201453
+6K141601Iassist Knee SystemZimmer Cas20142—
+6K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+6K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+6K140808Q-StationPhilips Ultrasound, Inc.201402
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+6K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+6K130617RaystationRaysearch Laboratories AB2013216
+6K120812RenaissanceMazor Robotics, Ltd.2012211
+6K113228Renaissance SystemMazor Robotics, Ltd.201123—
+6K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+6K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+6K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+6K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+7K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+7K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+7K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+7K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG20250—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+7K250086OTS HipOrtoma AB202511
+7K243069Lumys (V1)Intradys20250—
+7K243697MySpine WebPlannerMedacta International S.A.20250—
+7K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+7K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+7K240926PeekMed webPeek Health, S.A.20246—
+7K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+7K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+7K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+7K240172Preview ShoulderGenesis Software Innovations20240—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K232086spineEOSEos Imaging20235—
+7K230045HipCheckStryker Corp.20230—
+7K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+7K222803OncospaceOncospace, Inc.20233—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K221725Advanced MyHip PlannerMedacta International S.A.20230—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+7K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K213922FX SPSPixee Medical20222—
+7K213877ExactechGPS® SystemBlue Ortho20221—
+7K213779Customize3D-Side S.A.20221—
+7K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+7K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+7K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+7K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+7K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K200655FibroScan® 630Echosens20200—
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+7K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+7K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+7K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+7K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+7K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+7K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180307Mazor XMazor Robotics, Ltd.201817—
+7K173390hipEOSOnefit Medical20188—
+7K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+7K180091UNiD Spine AnalyzerMedicrea International20186—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K171677Clear Guide SCENERGYClear Guide Medical20173—
+7K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+7K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+7K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K172522Mazor XMazor Robotics, Ltd.20170—
+7K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+7K170841BiopSee, Mobile USMedcom GmbH20170—
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K170891Mako Partial Knee ApplicationMako Surgical Corp.201723