510(k) Report

Devices descending from K073714

117 later devices reach Traumacad Version 2.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202519OrthoNext Platform SystemOrthofix Srl20201—
+1K182464PeekMedPeek Health, S.A.201817—
+1K173329jFit Surgical PlannerJointvue, LLC20170—
+1K161828kneeEOSOnefit Medical20162—
+1K160284JointPointJointpoint, Inc.201621—
+1K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+1K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+1K142671Onefit Hip PlannerOnefit Medical201410—
+1K141669SurgimapNemaris, Inc.201427—
+1K140434Medicad ClassicHectec GmbH20140—
+1K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+1K120115OrthosizeOrthosize, LLC201201
+1K111019Surgimap (TM) SpineNemaris, Inc.201151—
+2K261861SPINEsim v1.0Mdsim S.A.20260—
+2K2613522D Hip Planning SoftwareOne Ortho20260—
+2K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+2K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+2K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+2K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+2K242270OrthoNext Platform SystemOrthofix Srl20240—
+2K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+2K231498TraumaCad NeoBrainlab, Ltd.20231—
+2K230252OFIX MIS AppOrthofix US, LLC20230—
+2K223841KBA3DS.M.A.I.O20231—
+2K213272Formus HipFormus Labs, Ltd.20230—
+2K221796Cyware 4H and Cysart 4HAbys Medical20221—
+2K222767PeekMed web (v1)Peek Health, S.A.20228—
+2K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+2K210344inVisionOSPrecisionos Technology, Inc.20210—
+2K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+2K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+2K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+2K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+2K210556Preview ShoulderGenesis Software Innovations20213—
+2K203651CuptimizeCuptimize, Inc.20213—
+2K200350MyHip Planner & VerifierMedacta International S.A.20201—
+2K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+2K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+2K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+2K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+2K170172UNiD Spine AnalyzerMedicrea International20177—
+2K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+2K163221Mazor XMazor Robotics, Ltd.201719—
+2K161479hipEOSOnefit Medical20169—
+2K160407spineEOSOnefit Medical20166—
+2K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+3K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+3K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+3K243069Lumys (V1)Intradys20250—
+3K243697MySpine WebPlannerMedacta International S.A.20250—
+3K240926PeekMed webPeek Health, S.A.20246—
+3K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+3K240172Preview ShoulderGenesis Software Innovations20240—
+3K232086spineEOSEos Imaging20235—
+3K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+3K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K221725Advanced MyHip PlannerMedacta International S.A.20230—
+3K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+3K213922FX SPSPixee Medical20222—
+3K213779Customize3D-Side S.A.20221—
+3K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+3K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+3K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+3K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+3K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+3K180307Mazor XMazor Robotics, Ltd.201817—
+3K173390hipEOSOnefit Medical20188—
+3K180091UNiD Spine AnalyzerMedicrea International20186—
+3K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+3K172522Mazor XMazor Robotics, Ltd.20170—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+4K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+4K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+4K252214AIAS CephalonMetamorphosis GmbH20250—
+4K250290SurgiTwinTwinsight20250—
+4K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+4K250042PeekMed webPeek Health, S.A.20254—
+4K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+4K240582VEA Align; spineEOSEos Imaging20244—
+4K221432Customize3D-Side S.A.20220—
+4K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+4K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+5K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+5K251747VEA Align; spineEOSEos Imaging20251—
+5K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+5K251096PeekMed webPeek Health, S.A.20253—
+5K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+5K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K200935Mazor XMazor Robotics, Ltd.202015—
+6K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+6K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+6K252856PeekMed webPeek Health, S.A.20251—
+6K251078AutoDensityEos Imaging20250—
+6K252452PeekMed webPeek Health, S.A.20250—