510(k) Report

Devices descending from K003589

882 later devices reach Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K231061NeuroBlate SystemMonteris Medical,20236—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+6K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+6K231886SURGIVISIO DeviceEcential Robotics20236—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+6K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223279RT Elements (4.0)Brainlab AG20231—
+6K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K203751OMNIVision systemCorin USA20210—
+6K203205Navigated Spine InstrumentsStryker Spine20218—
+6K202284OncospaceOncospace, Inc.20214—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202749ADAPT for Gamma3Stryker GmbH20200—
+6K202307Activ FuseNewclip Technics20200—
+6K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+6K192653PerseusOrthokey Italia S.R.L.20200—
+6K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+6K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+6K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+6K200511ROSA ONE Brain applicationMedtech S.A20205Class I
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K191014Elements ViewerBrainlab AG20203—
+6K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+6K193375NeuroBlate SystemMonteris Medical,202010—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+6K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K183605Spine & Trauma NavigationBrainlab AG2019253
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K173305NeuroBlate SystemMonteris Medical,201712—
+6K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+6K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K170937VIPER PRIME navigated inserterMedos International SARL20176—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+6K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K170724NeuroBlate SystemMonteris Medical,201715—
+6K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+6K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+6K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K153004Clear Guide SCENERGYClear Guide Medical20164—
+6K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+6K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+6K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+6K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+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—
+6K141983Neuroblate SystemMonteris Medical Corp.2014182
+6K140596NAVIOBlue Belt Technologies, Inc.201421—
+6K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K140808Q-StationPhilips Ultrasound, Inc.201402
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+6K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191