510(k) Report

Devices descending from K970617

380 later devices reach CT-Modeller System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+4K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+4K211114Will3DHdx Will Corp.20210—
+4K210241ImplaStationProdigident, Inc.20210—
+4K210726ImmersiveTouchImmersivetouch, Inc.20211—
+4K193301coDiagnostiXDental Wings GmbH20210—
+4K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+4K210347VSP System3D Systems20211—
+4K203195Simpleware ScanIP MedicalSynopsys (Northern Europe), Ltd.20213—
+4K203290BonelogicDisior, Ltd.20215—
+4K200572Planmeca RomexisPlanmeca Oy20202—
+4K200810IPS CaseDesignerNobel Biocare AB20201—
+4K2022563Shape Implant Studio3Shape Medical A/S20201—
+4K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20200—
+4K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+4K190767AnatomicAlignerThe Methodist Hospital Research Institute D/B/A Houston20200—
+4K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20202—
+4K192040AVIEW ModelerCoreline Soft Co., Ltd.20190—
+4K191026Medip ProMedical IP Co., Ltd.20192—
+4K183489D2P3D Systems, Inc.20196—
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K190096R2GATEMegagen Implant Co., Ltd.20191—
+4K190874Materialise Mimics EnlightMaterialise NV20192—
+4K182359HipCheckStryker Corp.20181—
+4K181926InVivo Web ViewerAnatomage, Inc.20180—
+4K173390hipEOSOnefit Medical20188—
+4K172239Simplant 18Dentsply Sirona20180—
+4K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+4K171385Planmeca RomexisPlanmeca Oy20171—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K1711153D Endo SoftwareDentsply Sirona20171—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K170419SurgiCase ViewerMaterialise NV20173—
+4K162559Move Forward 3D Motion Simulation ServiceBiomet, Inc.20172—
+4K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+4K163122NobelClinician, DTX Studio implantNobel Biocare AB20172—
+4K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+4K153705PROcedure Rehearsal Studio3Dsystems, Simbionix Products20160—
+4K161118SIMPLANT Online Case Review and SIMPLANT EditorDentsply Sirona20160—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K153091Implant 3DMedia Lab S.R.L.20160—
+4K151152ImplantMax SoftwareSaturn Imaging, Inc.20160—
+4K152078Implant Studio 20153Shape Medical A/S20157—
+4K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+4K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+4K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+4K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+4K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+4K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K140860ImmersiveTouch3 and MicrovisTouchImmersivetouch201401
+4K141570Implant Studio3Shape Medical A/S20148—
+4K140713Planmeca RomexisPlanmeca Oy201414—
+4K132290Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV201418—
+4K140257Signature Planner, Signature GuidesMaterialise NV20140—
+4K140093TABLEAnatomage, Inc.20144—
+4K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+4K131129Cas Psi ShoulderZimmer Cas201339—
+4K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+4K123023Surgery Rehearsal PlatformSurgical Theater, LLC201337—
+4K123269Procedure Rehearsal StudioSimbionix, Ltd.20131—
+4K121640Zimmer Patient Specific Instruments SystemMaterialise NV2012601
+4K120733Simplant GOMaterialise Dental NV20120—
+4K113739Simplant Immediate Smile Dental Care SystemMaterialise Dental NV20123—
+4K113829Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…Materialise NV201213—
+4K112679Simplant Navigator Personalized Dental Care SystemMaterialise Dental NV20120—
+4K110415Signature Planner / Signature GuidesMaterialise NV2011131
+5K262442HipStudio AnalysisReplasia BV20260—
+5K253902RealGUIDE3DIEMME SRL20260—
+5K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K253628Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd.20260—
+5K260116CustoMED ViewerCustoMED, Ltd.20260—
+5K260716NeowiseCefla S.C.20260—
+5K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+5K252195ARTICOR plannerArtiness S.R.L20260—
+5K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K251514Overjet CBCT AssistOverjet, Inc.20250—
+5K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+5K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+5K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+5K241961Vent Creativity Knee v1.0 (Hermes)Vent Creativity20250—
+5K233217Mimics Cardiac PlannerMaterialise NV20240—
+5K231607Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited20240—
+5K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+5K223757BonelogicDisior, Ltd.20234—
+5K223909R2GATE Lite TMMegagen Implant Co., Ltd.20230—
+5K230045HipCheckStryker Corp.20230—
+5K222745Axial3D InsightAxial Medical Printing Limited20232—
+5K223556DeepCatchMedical IP Co., Ltd.20231—
+5K2301193D Anatomic ModelRicoh USA, Inc.20230—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K222757Clarus ViewerClarus Viewer Corporation20230—
+5K230012Atomica PlannerAtomica Technology, Inc.20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20221—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+5K201835Pre-SureLazarus 3D, Inc.20211—