510(k) Report

Devices descending from K010602

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+6K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+6K250086OTS HipOrtoma AB202511
+6K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+6K242270OrthoNext Platform SystemOrthofix Srl20240—
+6K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+6K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+6K231498TraumaCad NeoBrainlab, Ltd.20231—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K230252OFIX MIS AppOrthofix US, LLC20230—
+6K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K223841KBA3DS.M.A.I.O20231—
+6K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+6K213272Formus HipFormus Labs, Ltd.20230—
+6K223279RT Elements (4.0)Brainlab AG20231—
+6K223351Naviswiss KneeNaviswiss AG20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K222767PeekMed web (v1)Peek Health, S.A.20228—
+6K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+6K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K210344inVisionOSPrecisionos Technology, Inc.20210—
+6K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+6K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+6K210556Preview ShoulderGenesis Software Innovations20213—
+6K202284OncospaceOncospace, Inc.20214—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K191014Elements ViewerBrainlab AG20203—
+6K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+6K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+6K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+6K170172UNiD Spine AnalyzerMedicrea International20177—
+6K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+6K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+6K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+6K163221Mazor XMazor Robotics, Ltd.201719—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+6K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K161479hipEOSOnefit Medical20169—
+6K160407spineEOSOnefit Medical20166—
+6K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+6K153004Clear Guide SCENERGYClear Guide Medical20164—
+6K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+6K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+6K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+6K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+6K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+6K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+6K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+6K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+6K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+6K141137Stereos WorkstationEos Imaging20149—
+6K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+6K140808Q-StationPhilips Ultrasound, Inc.201402
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+6K130617RaystationRaysearch Laboratories AB2013216
+6K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+6K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+6K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+6K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+7K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+7K261852OTS HipOrtoma AB20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+7K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG20250—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+7K243069Lumys (V1)Intradys20250—
+7K243697MySpine WebPlannerMedacta International S.A.20250—
+7K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+7K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+7K240926PeekMed webPeek Health, S.A.20246—