510(k) Report

Devices descending from K042816

129 later devices reach Traumacad 1.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211876Intellijoint VIEWIntellijoint Surgical, Inc.20210—
+1K160284JointPointJointpoint, Inc.201621—
+1K073714Traumacad Version 2.0Orthocrat, Ltd.2008117—
+1K073271OrthogonAgfa Healthcare Corporation20070—
+1K063327OrthoviewMerdian Technique, Ltd.200613—
+2K253551VELYS™ Hip NavigationDepuy Ireland UC20260—
+2K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited20250—
+2K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+2K203651CuptimizeCuptimize, Inc.20213—
+2K200350MyHip Planner & VerifierMedacta International S.A.20201—
+2K202519OrthoNext Platform SystemOrthofix Srl20201—
+2K201928e-Ortho Shoulder SoftwareFH Industrie20204—
+2K182332PhantomMSKOrthoGrid Systems, Inc.20195—
+2K182464PeekMedPeek Health, S.A.201817—
+2K173329jFit Surgical PlannerJointvue, LLC20170—
+2K171068OrthoView 7.2Meridian Technique, Ltd.20170—
+2K161828kneeEOSOnefit Medical20162—
+2K160001TraumaCad Mobile Release 2.0Voyant Health, Ltd.20163—
+2K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd.201528—
+2K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+2K142671Onefit Hip PlannerOnefit Medical201410—
+2K141669SurgimapNemaris, Inc.201427—
+2K140434Medicad ClassicHectec GmbH20140—
+2K133022ZedviewLexi Co., Ltd.201410—
+2K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+2K120115OrthosizeOrthosize, LLC201201
+2K111019Surgimap (TM) SpineNemaris, Inc.201151—
+3K261861SPINEsim v1.0Mdsim S.A.20260—
+3K2613522D Hip Planning SoftwareOne Ortho20260—
+3K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+3K251863CustomSurg OrthoPlannerCustomsurg AG20250—
+3K242270OrthoNext Platform SystemOrthofix Srl20240—
+3K233761Orthopaedic Surgery Planning Software (AIJOINT)Longwood Valley Medical, Ltd.20240—
+3K231498TraumaCad NeoBrainlab, Ltd.20231—
+3K230252OFIX MIS AppOrthofix US, LLC20230—
+3K231503CUPTIMIZE™ AdvancedDePuy Orthopaedics, Inc.20231—
+3K223841KBA3DS.M.A.I.O20231—
+3K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+3K213272Formus HipFormus Labs, Ltd.20230—
+3K221725Advanced MyHip PlannerMedacta International S.A.20230—
+3K221796Cyware 4H and Cysart 4HAbys Medical20221—
+3K222767PeekMed web (v1)Peek Health, S.A.20228—
+3K220758e-Ortho Shoulder Software v1.1FH Industrie20220—
+3K213922FX SPSPixee Medical20222—
+3K213975KEOPS Balance Analyzer 3DS.M.A.I.O20222—
+3K210344inVisionOSPrecisionos Technology, Inc.20210—
+3K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+3K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG20210—
+3K211386MySpine WebPlanner & MyBalanceMedacta International S.A.20211—
+3K200704ZedViewLexi Co., Ltd.20210—
+3K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+3K210556Preview ShoulderGenesis Software Innovations20213—
+3K210136PhantomMSK HipOrthoGrid Systems, Inc.20213—
+3K192279PhantomMSK TraumaOrthoGrid Systems, Inc.20190—
+3K183544Efficient Care 3D PlanningOrthosoft Inc (D/B/A Zimmer Cas)20191—
+3K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited20186—
+3K171617OKI Surgical Planning SoftwareOrtho Kinematics, Inc.20171—
+3K170172UNiD Spine AnalyzerMedicrea International20177—
+3K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+3K163221Mazor XMazor Robotics, Ltd.201719—
+3K163405360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited20170—
+3K161479hipEOSOnefit Medical20169—
+3K160407spineEOSOnefit Medical20166—
+3K142648SPINEDESIGN Spine Surgery Planning (Software Application)Medtronic Sofamor Danek USA, Inc.20150—
+4K261500KBA3D (v2.4.0)S.M.A.I.O20260—
+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—
+4K243810TraumaCad Neo (1.1)Brainlab, Ltd.20250—
+4K243069Lumys (V1)Intradys20250—
+4K243697MySpine WebPlannerMedacta International S.A.20250—
+4K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+4K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+4K240926PeekMed webPeek Health, S.A.20246—
+4K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+4K240172Preview ShoulderGenesis Software Innovations20240—
+4K232086spineEOSEos Imaging20235—
+4K213779Customize3D-Side S.A.20221—
+4K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+4K183038Corin Optimized Positioning System (OPS) PlanCorin USA20185—
+4K180307Mazor XMazor Robotics, Ltd.201817—
+4K173390hipEOSOnefit Medical20188—
+4K180091UNiD Spine AnalyzerMedicrea International20186—
+4K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+4K172522Mazor XMazor Robotics, Ltd.20170—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K250290SurgiTwinTwinsight20250—
+5K250042PeekMed webPeek Health, S.A.20254—
+5K240582VEA Align; spineEOSEos Imaging20244—
+5K221432Customize3D-Side S.A.20220—
+5K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+5K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162