510(k) Report

Devices descending from K050751

135 later devices reach Impax Orthopaedic Workstation, Model Impax ES 5.X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp.2007133—
+1K071297Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp.200701
+2K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+2K140434Medicad ClassicHectec GmbH20140—
+2K111945Impax Next GenerationAgfa Healthcare N.V.201122
+2K101398Stereos WorkstationBiospace Med2011121
+2K080529Stereos WorkstationBiospace Med200814—
+2K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+2K073271OrthogonAgfa Healthcare Corporation20070—
+3K202519OrthoNext Platform SystemOrthofix Srl20201—
+3K182464PeekMedPeek Health, S.A.201817—
+3K173329jFit Surgical PlannerJointvue, LLC20170—
+3K161828kneeEOSOnefit Medical20162—
+3K160284JointPointJointpoint, Inc.201621—
+3K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+3K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+3K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K142671Onefit Hip PlannerOnefit Medical201410—
+3K141669SurgimapNemaris, Inc.201427—
+3K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+3K130395Stereos WorkstationEos Imaging, Inc.2013101
+3K113344Stereos WorkstationEos Imaging201211—
+3K120115OrthosizeOrthosize, LLC201201
+3K111019Surgimap (TM) SpineNemaris, Inc.201151—
+3K090050Stereos WorkstationBiospace Med201013—
+4K261861SPINEsim v1.0Mdsim S.A.20260—
+4K2613522D Hip Planning SoftwareOne Ortho20260—
+4K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+4K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+4K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+4K242270OrthoNext Platform SystemOrthofix Srl20240—
+4K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+4K231498TraumaCad NeoBrainlab, Ltd.20231—
+4K230252OFIX MIS AppOrthofix US, LLC20230—
+4K223841KBA3DS.M.A.I.O20231—
+4K213272Formus HipFormus Labs, Ltd.20230—
+4K221796Cyware 4H and Cysart 4HAbys Medical20221—
+4K222767PeekMed web (v1)Peek Health, S.A.20228—
+4K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+4K210344inVisionOSPrecisionos Technology, Inc.20210—
+4K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+4K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+4K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+4K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+4K210556Preview ShoulderGenesis Software Innovations20213—
+4K203651CuptimizeCuptimize, Inc.20213—
+4K200350MyHip Planner & VerifierMedacta International S.A.20201—
+4K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+4K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+4K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+4K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+4K170172UNiD Spine AnalyzerMedicrea International20177—
+4K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+4K163221Mazor XMazor Robotics, Ltd.201719—
+4K161479hipEOSOnefit Medical20169—
+4K160407spineEOSOnefit Medical20166—
+4K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+4K141137Stereos WorkstationEos Imaging20149—
+5K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+5K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+5K243069Lumys (V1)Intradys20250—
+5K243697MySpine WebPlannerMedacta International S.A.20250—
+5K240926PeekMed webPeek Health, S.A.20246—
+5K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+5K240172Preview ShoulderGenesis Software Innovations20240—
+5K232086spineEOSEos Imaging20235—
+5K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+5K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+5K221725Advanced MyHip PlannerMedacta International S.A.20230—
+5K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+5K213922FX SPSPixee Medical20222—
+5K213779Customize3D-Side S.A.20221—
+5K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+5K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+5K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+5K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+5K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+5K180307Mazor XMazor Robotics, Ltd.201817—
+5K173390hipEOSOnefit Medical20188—
+5K180091UNiD Spine AnalyzerMedicrea International20186—
+5K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+5K172522Mazor XMazor Robotics, Ltd.20170—
+5K160914sterEOS WorkstationEos Imaging, Inc.20168—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+6K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+6K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+6K252214AIAS CephalonMetamorphosis GmbH20250—
+6K250290SurgiTwinTwinsight20250—
+6K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+6K250042PeekMed webPeek Health, S.A.20254—
+6K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+6K240582VEA Align; spineEOSEos Imaging20244—
+6K221432Customize3D-Side S.A.20220—
+6K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+6K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162