510(k) Report

Devices descending from K983831

611 later devices reach VECTORVISION2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+5K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+5K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+5K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+6K253954X-Guide Surgical Navigation SystemX-Nav Technologies, LLC20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+6K250086OTS HipOrtoma AB202511
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+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—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K234047Automatic RegistrationBrainlab AG20240—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+6K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+6K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+6K231886SURGIVISIO DeviceEcential Robotics20236—
+6K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+6K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K222049Yomi Robotic SystemNeocis, Inc.20224—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+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
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K203751OMNIVision systemCorin USA20210—
+6K203205Navigated Spine InstrumentsStryker Spine20218—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202749ADAPT for Gamma3Stryker GmbH20200—
+6K202307Activ FuseNewclip Technics20200—
+6K192653PerseusOrthokey Italia S.R.L.20200—
+6K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+6K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+6K200511ROSA ONE Brain applicationMedtech S.A20205Class I
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc.20190—
+6K191605Neocis Guidance System (NGS)Neocis, Inc.20190—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+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
+6K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+6K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+6K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+6K140596NAVIOBlue Belt Technologies, Inc.201421—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K121936NaviopfsBlue Belt Technologies, Inc.2012222
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K103829Kneealign SystemOrthalign, Inc.201139—
+6K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+7K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+7K262315NeuroBlate SystemMonteris Medical20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261852OTS HipOrtoma AB20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—