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
+5K221028SURGIVISIO DeviceEcential Robotics20227—
+5K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+5K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+5K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+5K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationBrainlab AG20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+5K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Brainlab AG20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+5K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+5K192173ROSA ONE Spine applicationMedtech S.A20190—
+5K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+5K191285Spine & Trauma NavigationBrainlab AG20190—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K182036NeuroBlate SystemMonteris Medical,201811—
+5K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+5K162314IMACTIS CT-Navigation systemImactis, Sas201804
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+5K172881NeuroBlate SystemMonteris Medical,201713—
+5K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+5K163666neuro inspireRensihaw Plc20170—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+5K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+5K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K153653DICOM ViewerBrainlab AG20164—
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+5K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+5K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K140927Universal Navigation InstrumentsMedos International SARL20141—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K140254EZONO 4000Ezono AG201413—
+5K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+5K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+5K132087Percunav SystemPhilips Health Care20139—
+5K120561Neuroblate SystemMonteris Medical, Inc.2013211
+5K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+5K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine201220—
+5K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+5K120867Viper and Expedium Navigated InstrumentsMedos International SARL20122—
+5K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+5K120387RaystationRaysearch Laboratories AB2012226
+5K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+5K102990Brainlab KneeBrainlab AG201171
+5K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+5K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+5K091411Kneealign SystemOrthalign, Inc.200941—
+5K083310Spine & Trauma IctBrainlab AG200940—
+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—
+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—
+6K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+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—
+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—