510(k) Report

Devices descending from K010612

838 later devices reach Vectorvision Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K100742Exactech GPSBlue Ortho201020—
+4K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+4K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+4K100314Imns Medacta Navigation System,33.221000USMedacta International S.A.201013—
+4K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+4K093117Digital LightboxBrainlab AG200952
+4K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+4K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc.20090—
+4K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+4K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+4K080529Stereos WorkstationBiospace Med200814—
+4K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+4K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+4K072271Stryker Navigation System Infinitus Hip Resurfacing ModuleStryker Corp.20070—
+4K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+4K073271OrthogonAgfa Healthcare Corporation20070—
+4K071929Navitrack System- Partial Hip Resurfacing UniversalOrthosoft, Inc.200723
+4K071714Navitrack System - OS Unicondylar Knee Universal, Model# Pro-06003Orthosoft, Inc.2007792
+4K071135Depuy CI Hip InstrumentationDePuy Orthopaedics, Inc.20070—
+4K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+4K060210MediportMaxant Technologies, Inc.20060—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationBrainlab AG20211—
+5K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Brainlab AG20212—
+5K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+5K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+5K202519OrthoNext Platform SystemOrthofix Srl20201—
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K193307HIP7Brainlab AG20200—
+5K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+5K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+5K182464PeekMedPeek Health, S.A.201817—
+5K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+5K162314IMACTIS CT-Navigation systemImactis, Sas201804
+5K173329jFit Surgical PlannerJointvue, LLC20170—
+5K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+5K163666neuro inspireRensihaw Plc20170—
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+5K161999AixplorerSupersonic Imagine201620—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K161828kneeEOSOnefit Medical20162—
+5K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+5K160284JointPointJointpoint, Inc.201621—
+5K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+5K152764Exactech GPSBlue Ortho2016191
+5K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+5K153653DICOM ViewerBrainlab AG20164—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+5K142671Onefit Hip PlannerOnefit Medical201410—
+5K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+5K141669SurgimapNemaris, Inc.201427—
+5K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+5K140596NAVIOBlue Belt Technologies, Inc.201421—
+5K140331Orthalign Plus SystemOrthalign, Inc.201429—
+5K140677MylabssognoEsaote, S.p.A.20140—
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K140254EZONO 4000Ezono AG201413—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+5K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+5K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+5K132087Percunav SystemPhilips Health Care20139—
+5K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+5K130395Stereos WorkstationEos Imaging, Inc.2013101
+5K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+5K121936NaviopfsBlue Belt Technologies, Inc.2012222
+5K122326Smarttools Knee SystemZimmer201232
+5K113344Stereos WorkstationEos Imaging201211—
+5K121384MylabsognoEsaote, S.p.A.201211
+5K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+5K120387RaystationRaysearch Laboratories AB2012226
+5K120115OrthosizeOrthosize, LLC201201
+5K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+5K111019Surgimap (TM) SpineNemaris, Inc.201151—
+5K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+5K110688MylabgoldEsaote2011251
+5K110911Renaissance SystemMazor Robotics, Ltd.201124—
+5K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+5K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc.20101—
+5K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+5K090050Stereos WorkstationBiospace Med201013—
+5K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+6K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—