510(k) Report

Devices descending from K010602

715 later devices reach Vectorvision Hip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+4K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+4K140434Medicad ClassicHectec GmbH20140—
+4K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+4K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+4K121498PercunavPhilips Health Care2012222—
+4K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+4K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+4K111945Impax Next GenerationAgfa Healthcare N.V.201122
+4K101627IPLANBrainlab AG201112—
+4K103246Iplan RTBrainlab AG2011322
+4K101398Stereos WorkstationBiospace Med2011121
+4K100599Cas Fixation Pin 3.2 Dia X 180 MM STR, Cas Fixaton Pin 3.2 Dia X 80 MM STR, Cas Fixaton…Orthosoft, Inc.20101—
+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—
+4K090313Pigalileo TKR Base V2.3 and Cas V4.1Smith & Nephew, Inc.20090—
+4K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+4K080529Stereos WorkstationBiospace Med200814—
+4K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+4K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+4K073271OrthogonAgfa Healthcare Corporation20070—
+4K060210MediportMaxant Technologies, Inc.20060—
+5K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+5K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+5K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+5K252214AIAS CephalonMetamorphosis GmbH20250—
+5K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K242569Mixed Reality Spine NavigationBrainlab AG20250—
+5K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+5K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+5K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+5K232140OTS HipOrtoma AB202421
+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—
+5K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+5K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+5K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+5K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+5K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+5K182464PeekMedPeek Health, S.A.201817—
+5K162314IMACTIS CT-Navigation systemImactis, Sas201804
+5K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+5K173329jFit Surgical PlannerJointvue, LLC20170—
+5K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+5K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+5K163666neuro inspireRensihaw Plc20170—
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K161828kneeEOSOnefit Medical20162—
+5K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+5K153653DICOM ViewerBrainlab AG20164—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+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—
+5K141669SurgimapNemaris, Inc.201427—
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K140254EZONO 4000Ezono AG201413—
+5K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+5K132087Percunav SystemPhilips Health Care20139—
+5K131130Navigation PinEvergreen Orthopedic Research Lab20130—
+5K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+5K130395Stereos WorkstationEos Imaging, Inc.2013101
+5K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+5K113344Stereos WorkstationEos Imaging201211—
+5K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+5K120387RaystationRaysearch Laboratories AB2012226
+5K120115OrthosizeOrthosize, LLC201201
+5K111019Surgimap (TM) SpineNemaris, Inc.201151—
+5K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+5K090050Stereos WorkstationBiospace Med201013—
+5K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+6K261861SPINEsim v1.0Mdsim S.A.20260—
+6K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+6K2613522D Hip Planning SoftwareOne Ortho20260—