510(k) Report

Devices descending from K183105

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254214OoopdsTaiwan Main Orthopaedic Biotechnology Co., Ltd.20260—
+1K251964Mimics Thoracic PlannerMaterialise NV20260—
+1K242647MySegmenter (v2.0.0)Mysegmenter Technologies, Inc.20250—
+1K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20243—
+1K223427Mimics Enlight CMFMaterialise NV20240—
+1K231955aprevo® Digital SegmentationCarlsmed, Inc.20231—
+1K230540Patient Specific Planning Solution™ 3D Bone ModelsBiomet Manufacturing Corp20230—
+1K222987Akunah REFLECTAkunah Pty, Ltd.20231—
+1K220649ElucisRealize Medical, Inc.20230—
+1K222577TECHFIT Diagnostic ModelsTechfit Digital Surgery, Inc.20230—
+1K213684SurgiCase ViewerMaterialise NV20221—
+1K211966Segment 3DPrintMedviso AB20220—
+1K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+1K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+1K210726ImmersiveTouchImmersivetouch, Inc.20211—
+1K203290BonelogicDisior, Ltd.20215—
+1K190874Materialise Mimics EnlightMaterialise NV20192—
+2K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+2K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+2K253628Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)Agada Medical, Ltd.20260—
+2K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+2K252195ARTICOR plannerArtiness S.R.L20260—
+2K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+2K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20250—
+2K233217Mimics Cardiac PlannerMaterialise NV20240—
+2K223757BonelogicDisior, Ltd.20234—
+2K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+2K222757Clarus ViewerClarus Viewer Corporation20230—
+3K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+3K250023Smart PCFDDisior, Ltd.20250—
+3K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+3K240736SMART Bun-Yo-Matic X-RayDisior, Ltd.20240—
+3K240642SMART Bun-Yo-Matic CTDisior, Ltd.20242—
+4K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—