510(k) Report

Devices descending from K983831

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K232140OTS HipOrtoma AB202421
+5K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC202412
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231061NeuroBlate SystemMonteris Medical,20236—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230045HipCheckStryker Corp.20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+5K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+5K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+5K221028SURGIVISIO DeviceEcential Robotics20227—
+5K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.20220—
+5K211529NAVIRFA ScopeNavifus Corporation20220—
+5K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+5K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc.20215—
+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—
+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—
+5K203679Automatic RegistrationBrainlab AG20211—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+5K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Neocis, Inc.20200—
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+5K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)Neocis, Inc.20200—
+5K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+5K193375NeuroBlate SystemMonteris Medical,202010—
+5K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+5K192173ROSA ONE Spine applicationMedtech S.A20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+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—
+5K182776Neocis Guidance SystemNeocis, Inc.20182—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K173305NeuroBlate SystemMonteris Medical,201712—
+5K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K170724NeuroBlate SystemMonteris Medical,201715—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+5K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+5K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+5K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+5K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141983Neuroblate SystemMonteris Medical Corp.2014182
+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
+5K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+5K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+5K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+5K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+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—
+5K091411Kneealign SystemOrthalign, Inc.200941—