510(k) Report

Devices descending from K014113

139 later devices reach Endomap through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050751Impax Orthopaedic Workstation, Model Impax ES 5.XAgfa Corp.20051353
+1K040344Impax OT3000 Orthopedic WorkstationAgfa Corp.20042—
+2K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp.2007133—
+2K071297Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp.200701
+2K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.20041—
+3K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+3K140434Medicad ClassicHectec GmbH20140—
+3K111945Impax Next GenerationAgfa Healthcare N.V.201122
+3K101398Stereos WorkstationBiospace Med2011121
+3K080529Stereos WorkstationBiospace Med200814—
+3K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+3K073271OrthogonAgfa Healthcare Corporation20070—
+3K060210MediportMaxant Technologies, Inc.20060—
+4K202519OrthoNext Platform SystemOrthofix Srl20201—
+4K182464PeekMedPeek Health, S.A.201817—
+4K173329jFit Surgical PlannerJointvue, LLC20170—
+4K161828kneeEOSOnefit Medical20162—
+4K160284JointPointJointpoint, Inc.201621—
+4K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+4K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K142671Onefit Hip PlannerOnefit Medical201410—
+4K141669SurgimapNemaris, Inc.201427—
+4K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+4K130395Stereos WorkstationEos Imaging, Inc.2013101
+4K113344Stereos WorkstationEos Imaging201211—
+4K120115OrthosizeOrthosize, LLC201201
+4K111019Surgimap (TM) SpineNemaris, Inc.201151—
+4K090050Stereos WorkstationBiospace Med201013—
+5K261861SPINEsim v1.0Mdsim S.A.20260—
+5K2613522D Hip Planning SoftwareOne Ortho20260—
+5K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+5K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+5K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+5K242270OrthoNext Platform SystemOrthofix Srl20240—
+5K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+5K231498TraumaCad NeoBrainlab, Ltd.20231—
+5K230252OFIX MIS AppOrthofix US, LLC20230—
+5K223841KBA3DS.M.A.I.O20231—
+5K213272Formus HipFormus Labs, Ltd.20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K222767PeekMed web (v1)Peek Health, S.A.20228—
+5K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+5K210344inVisionOSPrecisionos Technology, Inc.20210—
+5K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+5K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+5K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+5K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+5K210556Preview ShoulderGenesis Software Innovations20213—
+5K203651CuptimizeCuptimize, Inc.20213—
+5K200350MyHip Planner & VerifierMedacta International S.A.20201—
+5K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+5K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+5K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+5K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+5K170172UNiD Spine AnalyzerMedicrea International20177—
+5K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+5K163221Mazor XMazor Robotics, Ltd.201719—
+5K161479hipEOSOnefit Medical20169—
+5K160407spineEOSOnefit Medical20166—
+5K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+5K141137Stereos WorkstationEos Imaging20149—
+6K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+6K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+6K243069Lumys (V1)Intradys20250—
+6K243697MySpine WebPlannerMedacta International S.A.20250—
+6K240926PeekMed webPeek Health, S.A.20246—
+6K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+6K240172Preview ShoulderGenesis Software Innovations20240—
+6K232086spineEOSEos Imaging20235—
+6K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+6K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+6K221725Advanced MyHip PlannerMedacta International S.A.20230—
+6K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+6K213922FX SPSPixee Medical20222—
+6K213779Customize3D-Side S.A.20221—
+6K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+6K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+6K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+6K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+6K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+6K180307Mazor XMazor Robotics, Ltd.201817—
+6K173390hipEOSOnefit Medical20188—
+6K180091UNiD Spine AnalyzerMedicrea International20186—
+6K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+6K172522Mazor XMazor Robotics, Ltd.20170—
+6K160914sterEOS WorkstationEos Imaging, Inc.20168—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+7K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+7K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+7K252214AIAS CephalonMetamorphosis GmbH20250—
+7K250290SurgiTwinTwinsight20250—
+7K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+7K250042PeekMed webPeek Health, S.A.20254—
+7K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+7K240582VEA Align; spineEOSEos Imaging20244—
+7K221432Customize3D-Side S.A.20220—