510(k) Report

Devices descending from K983831

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231897NeuroAlign softwareMedivis, Inc.20250—
+4K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—
+4K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav20250—
+4K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+4K210947NavidentClaronav, Inc.20220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+4K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC202221
+4K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis, Inc.20210—
+4K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+4K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc.20200—
+4K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+4K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc.20207—
+4K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+4K201174TruDi CuretteAcclarent, Inc.20200—
+4K193307HIP7Brainlab AG20200—
+4K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+4K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+4K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+4K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+4K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+4K183605Spine & Trauma NavigationBrainlab AG2019253
+4K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+4K182848ROSA ONE Spine applicationMedtech S.A201910—
+4K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+4K182359HipCheckStryker Corp.20181—
+4K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+4K182036NeuroBlate SystemMonteris Medical,201811—
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+4K173946ADAPT for Gamma3Stryker GmbH20182—
+4K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+4K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+4K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc.201854
+4K172881NeuroBlate SystemMonteris Medical,201713—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+4K170937VIPER PRIME navigated inserterMedos International SARL20176—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K161999AixplorerSupersonic Imagine201620—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+4K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+4K141806Clear Guide OneClear Guide Medical20142—
+4K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K120561Neuroblate SystemMonteris Medical, Inc.2013211
+4K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+4K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+4K121384MylabsognoEsaote, S.p.A.201211
+4K111443X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering20110—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K110688MylabgoldEsaote2011251
+4K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+4K103192Navigation Marker, Reflective Marker SpheresIlumark GmbH20111—
+4K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+4K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+4K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+4K080678Uni-Knee 2.0Brainlab AG20081—
+4K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+4K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+4K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+4K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+5K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+5K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K242569Mixed Reality Spine NavigationBrainlab AG20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+5K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—