510(k) Report

Devices descending from K120956

28 later devices reach VSP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212570OsteoPlan SystemOsteomed, LLC20221—
+1K192282MedCAD® AccuPlan® SystemMedcad20203—
+1K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+1K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+1K133907VSP SystemMedical Modeling, Inc.201481
+1K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K223427Mimics Enlight CMFMaterialise NV20240—
+2K231520tmCMF SolutionTechmah Cmf20231—
+2K223024MedCAD AccuPlan SystemMedcad20230—
+2K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+2K193499DigiGuide SystemProtomed, Inc.20200—
+2K192192VSP System3D Systems20203—
+2K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20191—
+2K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20197—
+2K151285VSP Cranial System3D Systems, Inc.20160—
+3K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.20260—
+3K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV20251—
+3K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.20240—
+3K233874tmCMF SolutionTechmah Cmf20240—
+3K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+3K220366EmbedMed3D Lifeprints UK, Ltd.20220—
+3K220648OMF ASP SystemVha Dean20220—
+3K210347VSP System3D Systems20211—
+3K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20200—
+3K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20202—
+4K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV20260—
+4K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20221—
+5K223421MedCAD AccuPlan Orthopedics SystemMedcad20230—