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
+4K182848ROSA ONE Spine applicationMedtech S.A201910—
+4K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+4K182359HipCheckStryker Corp.20181—
+4K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+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
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+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—
+4K151414IQQA GuideEdda Technology20151—
+4K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+4K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+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—
+4K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+4K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+4K121498PercunavPhilips Health Care2012222—
+4K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+4K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+4K121384MylabsognoEsaote, S.p.A.201211
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+4K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+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—
+4K101627IPLANBrainlab AG201112—
+4K110688MylabgoldEsaote2011251
+4K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+4K103246Iplan RTBrainlab AG2011322
+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
+4K093117Digital LightboxBrainlab AG200952
+4K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+4K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+4K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+4K080678Uni-Knee 2.0Brainlab AG20081—
+4K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+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—
+4K070106VV Fluoro 3DBrainlab AG2007119Class I
+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—
+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—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+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
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230045HipCheckStryker Corp.20230—
+5K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+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—