510(k) Report

Devices descending from K033849

379 later devices reach Simplant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K190874Materialise Mimics EnlightMaterialise NV20192—
+3K182359HipCheckStryker Corp.20181—
+3K181926InVivo Web ViewerAnatomage, Inc.20180—
+3K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+3K173390hipEOSOnefit Medical20188—
+3K172239Simplant 18Dentsply Sirona20180—
+3K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+3K171385Planmeca RomexisPlanmeca Oy20171—
+3K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+3K1711153D Endo SoftwareDentsply Sirona20171—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K170419SurgiCase ViewerMaterialise NV20173—
+3K162559Move Forward 3D Motion Simulation ServiceBiomet, Inc.20172—
+3K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+3K163122NobelClinician, DTX Studio implantNobel Biocare AB20172—
+3K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+3K153705PROcedure Rehearsal Studio3Dsystems, Simbionix Products20160—
+3K161118SIMPLANT Online Case Review and SIMPLANT EditorDentsply Sirona20160—
+3K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+3K153091Implant 3DMedia Lab S.R.L.20160—
+3K151152ImplantMax SoftwareSaturn Imaging, Inc.20160—
+3K152078Implant Studio 20153Shape Medical A/S20157—
+3K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+3K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+3K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+3K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+3K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+3K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K140860ImmersiveTouch3 and MicrovisTouchImmersivetouch201401
+3K141570Implant Studio3Shape Medical A/S20148—
+3K140713Planmeca RomexisPlanmeca Oy201414—
+3K132290Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV201418—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K140093TABLEAnatomage, Inc.20144—
+3K133907VSP SystemMedical Modeling, Inc.201481
+3K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+3K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+3K123023Surgery Rehearsal PlatformSurgical Theater, LLC201337—
+3K123269Procedure Rehearsal StudioSimbionix, Ltd.20131—
+3K121640Zimmer Patient Specific Instruments SystemMaterialise NV2012601
+3K120733Simplant GOMaterialise Dental NV20120—
+3K113739Simplant Immediate Smile Dental Care SystemMaterialise Dental NV20123—
+3K113829Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…Materialise NV201213—
+3K112679Simplant Navigator Personalized Dental Care SystemMaterialise Dental NV20120—
+3K110415Signature Planner / Signature GuidesMaterialise NV2011131
+4K262442HipStudio AnalysisReplasia BV20260—
+4K253902RealGUIDE3DIEMME SRL20260—
+4K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+4K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+4K253628Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd.20260—
+4K260116CustoMED ViewerCustoMED, Ltd.20260—
+4K260716NeowiseCefla S.C.20260—
+4K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+4K252195ARTICOR plannerArtiness S.R.L20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251514Overjet CBCT AssistOverjet, Inc.20250—
+4K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+4K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+4K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+4K241961Vent Creativity Knee v1.0 (Hermes)Vent Creativity20250—
+4K233217Mimics Cardiac PlannerMaterialise NV20240—
+4K231607Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited20240—
+4K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+4K223757BonelogicDisior, Ltd.20234—
+4K223909R2GATE Lite TMMegagen Implant Co., Ltd.20230—
+4K231520tmCMF SolutionTechmah Cmf20231—
+4K230045HipCheckStryker Corp.20230—
+4K222745Axial3D InsightAxial Medical Printing Limited20232—
+4K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+4K223556DeepCatchMedical IP Co., Ltd.20231—
+4K2301193D Anatomic ModelRicoh USA, Inc.20230—
+4K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+4K223024MedCAD AccuPlan SystemMedcad20230—
+4K222757Clarus ViewerClarus Viewer Corporation20230—
+4K230012Atomica PlannerAtomica Technology, Inc.20230—
+4K221796Cyware 4H and Cysart 4HAbys Medical20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+4K201835Pre-SureLazarus 3D, Inc.20211—
+4K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+4K200589MyPAO Planning ReportMedacta International S.A.20210—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K193499DigiGuide SystemProtomed, Inc.20200—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+4K200078VARO Plan3D Industrial Imaging Co., Ltd.20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192192VSP System3D Systems20203—
+4K192165Acteon Imaging SuiteDe Gotzen S.R.L.20200—
+4K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K183458exoplan 2.3Exocad GmbH20191—
+4K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20191—
+4K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—