510(k) Report

Devices descending from K060950

31 later devices reach 3MATIC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222195aprevo® Digital WorkflowCarlsmed, Inc.20221—
+1K120956VSP SystemMedical Modeling, Inc.201228—
+2K242599aprevo® Digital PlanningCarlsmed, Inc.20240—
+2K212570OsteoPlan SystemOsteomed, LLC20221—
+2K192282MedCAD® AccuPlan® SystemMedcad20203—
+2K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+2K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+2K133907VSP SystemMedical Modeling, Inc.201481
+2K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+3K223427Mimics Enlight CMFMaterialise NV20240—
+3K231520tmCMF SolutionTechmah Cmf20231—
+3K223024MedCAD AccuPlan SystemMedcad20230—
+3K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+3K193499DigiGuide SystemProtomed, Inc.20200—
+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—
+3K151285VSP Cranial System3D Systems, Inc.20160—
+4K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.20260—
+4K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV20251—
+4K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.20240—
+4K233874tmCMF SolutionTechmah Cmf20240—
+4K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+4K220366EmbedMed3D Lifeprints UK, Ltd.20220—
+4K220648OMF ASP SystemVha Dean20220—
+4K210347VSP System3D Systems20211—
+4K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20200—
+4K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20202—
+5K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV20260—
+5K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20221—
+6K223421MedCAD AccuPlan Orthopedics SystemMedcad20230—