510(k) Report

Devices descending from K073468

141 later devices reach Mimics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183105Mimics MedicalMaterialise NV201934—
+1K173619Mimics inPrintMaterialise NV201813—
+1K161841D2P3D Systems, Inc.20178—
+1K142779Scanip; Scanip: Medical Edition; Scanip: MedSimpleware, Ltd.201542
+1K132636Dyonics Plan Hip Impingement Planning SystemSmith & Nephew, Inc.201314—
+1K124051The Vault SystemSomersault Orthopedics, Inc.20131—
+1K120956VSP SystemMedical Modeling, Inc.201228—
+1K112387Procedure Rehearsal Studio (TM)Simbionix, Ltd.201140—
+1K093269Procedure Rehearsal StudioSimbionix, Ltd.201041—
+2K254214OoopdsTaiwan Main Orthopaedic Biotechnology Co., Ltd.20260—
+2K251964Mimics Thoracic PlannerMaterialise NV20260—
+2K242647MySegmenter (v2.0.0)Mysegmenter Technologies, Inc.20250—
+2K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20243—
+2K223427Mimics Enlight CMFMaterialise NV20240—
+2K231955aprevo® Digital SegmentationCarlsmed, Inc.20231—
+2K230540Patient Specific Planning Solution™ 3D Bone ModelsBiomet Manufacturing Corp20230—
+2K222987Akunah REFLECTAkunah Pty, Ltd.20231—
+2K220649ElucisRealize Medical, Inc.20230—
+2K222577TECHFIT Diagnostic ModelsTechfit Digital Surgery, Inc.20230—
+2K221511Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited20224—
+2K213684SurgiCase ViewerMaterialise NV20221—
+2K2202053D Anatomic ModelsRicoh USA, Inc.20221—
+2K211966Segment 3DPrintMedviso AB20220—
+2K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+2K212570OsteoPlan SystemOsteomed, LLC20221—
+2K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+2K210726ImmersiveTouchImmersivetouch, Inc.20211—
+2K202521PtoleMedic SystemLento Medical Innovation, Inc.20210—
+2K203195Simpleware ScanIP MedicalSynopsys (Northern Europe), Ltd.20213—
+2K203290BonelogicDisior, Ltd.20215—
+2K192282MedCAD® AccuPlan® SystemMedcad20203—
+2K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+2K192040AVIEW ModelerCoreline Soft Co., Ltd.20190—
+2K191026Medip ProMedical IP Co., Ltd.20192—
+2K183489D2P3D Systems, Inc.20196—
+2K190874Materialise Mimics EnlightMaterialise NV20192—
+2K182359HipCheckStryker Corp.20181—
+2K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+2K173390hipEOSOnefit Medical20188—
+2K162559Move Forward 3D Motion Simulation ServiceBiomet, Inc.20172—
+2K153705PROcedure Rehearsal Studio3Dsystems, Simbionix Products20160—
+2K140860ImmersiveTouch3 and MicrovisTouchImmersivetouch201401
+2K133907VSP SystemMedical Modeling, Inc.201481
+2K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K123023Surgery Rehearsal PlatformSurgical Theater, LLC201337—
+2K123269Procedure Rehearsal StudioSimbionix, Ltd.20131—
+3K262442HipStudio AnalysisReplasia BV20260—
+3K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+3K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+3K253628Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd.20260—
+3K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+3K252195ARTICOR plannerArtiness S.R.L20260—
+3K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+3K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+3K241961Vent Creativity Knee v1.0 (Hermes)Vent Creativity20250—
+3K233217Mimics Cardiac PlannerMaterialise NV20240—
+3K231607Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited20240—
+3K223757BonelogicDisior, Ltd.20234—
+3K231520tmCMF SolutionTechmah Cmf20231—
+3K230045HipCheckStryker Corp.20230—
+3K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+3K222745Axial3D InsightAxial Medical Printing Limited20232—
+3K223556DeepCatchMedical IP Co., Ltd.20231—
+3K2301193D Anatomic ModelRicoh USA, Inc.20230—
+3K223024MedCAD AccuPlan SystemMedcad20230—
+3K222757Clarus ViewerClarus Viewer Corporation20230—
+3K221796Cyware 4H and Cysart 4HAbys Medical20221—
+3K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+3K201835Pre-SureLazarus 3D, Inc.20211—
+3K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+3K200589MyPAO Planning ReportMedacta International S.A.20210—
+3K193499DigiGuide SystemProtomed, Inc.20200—
+3K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+3K192192VSP System3D Systems20203—
+3K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20191—
+3K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20197—
+3K170793SuRgical Planner (SRP)Surgical Theater, LLC201851
+3K151285VSP Cranial System3D Systems, Inc.20160—
+3K142107Echo True 3D ViewerEchopixel, Inc.2015271
+3K140819Surgical Navigation Advanced PlatformSurgical Theater, LLC20141—
+4K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+4K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.20260—
+4K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+4K250023Smart PCFDDisior, Ltd.20250—
+4K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+4K243069Lumys (V1)Intradys20250—
+4K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV20251—
+4K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.20240—
+4K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+4K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+4K233874tmCMF SolutionTechmah Cmf20240—
+4K240736SMART Bun-Yo-Matic X-RayDisior, Ltd.20240—
+4K240642SMART Bun-Yo-Matic CTDisior, Ltd.20242—
+4K232841Axial3D InsightAxial Medical Printing Limited20231—
+4K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+4K230044Pre-SureLazarus 3D20230—
+4K220366EmbedMed3D Lifeprints UK, Ltd.20220—
+4K220648OMF ASP SystemVha Dean20220—
+4K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+4K210347VSP System3D Systems20211—