510(k) Report

Devices descending from K010612

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261861SPINEsim v1.0Mdsim S.A.20260—
+6K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+6K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+6K2613522D Hip Planning SoftwareOne Ortho20260—
+6K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+6K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+6K242569Mixed Reality Spine NavigationBrainlab AG20250—
+6K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+6K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+6K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+6K242270OrthoNext Platform SystemOrthofix Srl20240—
+6K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+6K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+6K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+6K232140OTS HipOrtoma AB202421
+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—
+6K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+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—
+6K203651CuptimizeCuptimize, Inc.20213—
+6K200350MyHip Planner & VerifierMedacta International S.A.20201—
+6K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+6K192653PerseusOrthokey Italia S.R.L.20200—
+6K193618ExactechGPS SystemBlue Ortho202021
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K191014Elements ViewerBrainlab AG20203—
+6K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+6K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+6K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+6K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+6K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+6K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+6K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182359HipCheckStryker Corp.20181—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+6K173946ADAPT for Gamma3Stryker GmbH20182—
+6K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+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—
+6K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+6K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+6K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+6K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K163221Mazor XMazor Robotics, Ltd.201719—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+6K161479hipEOSOnefit Medical20169—
+6K160407spineEOSOnefit Medical20166—
+6K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+6K153004Clear Guide SCENERGYClear Guide Medical20164—
+6K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+6K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+6K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+6K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+6K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+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—