510(k) Report

Devices descending from K103136

90 later devices reach Surgicase CMF, Surgicase Connect, Surgicase Guide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120956VSP SystemMedical Modeling, Inc.201228—
+1K112389Surgicase Connect, Surgicase GuideMaterialise NV201259—
+1K111558Surgicase GuideMaterialise NV20120—
+2K212570OsteoPlan SystemOsteomed, LLC20221—
+2K192282MedCAD® AccuPlan® SystemMedcad20203—
+2K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200—
+2K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+2K132290Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV201418—
+2K133907VSP SystemMedical Modeling, Inc.201481
+2K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K131129Cas Psi ShoulderZimmer Cas201339—
+3K223427Mimics Enlight CMFMaterialise NV20240—
+3K231520tmCMF SolutionTechmah Cmf20231—
+3K223024MedCAD AccuPlan SystemMedcad20230—
+3K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20211—
+3K193499DigiGuide SystemProtomed, Inc.20200—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K192192VSP System3D Systems20203—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20191—
+3K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20197—
+3K170419SurgiCase ViewerMaterialise NV20173—
+3K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV20178—
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K151285VSP Cranial System3D Systems, Inc.20160—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K260116CustoMED ViewerCustoMED, Ltd.20260—
+4K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.20260—
+4K243509Archer PSI System3D-Side20250—
+4K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV20251—
+4K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.20240—
+4K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics20242—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K233874tmCMF SolutionTechmah Cmf20240—
+4K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics20233—
+4K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+4K220366EmbedMed3D Lifeprints UK, Ltd.20220—
+4K220648OMF ASP SystemVha Dean20220—
+4K213684SurgiCase ViewerMaterialise NV20221—
+4K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC20223—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+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—
+4K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+5K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV20260—
+5K241811MedCAD® AccuStride™ SystemMedcad20252—
+5K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics20251—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+5K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.20221—
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+5K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+6K252064MedCAD® AccuStride™ SystemMedcad20260—
+6K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+6K251709MedCAD® AccuStride™ SystemMedcad20250—
+6K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics20250—
+6K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K223421MedCAD AccuPlan Orthopedics SystemMedcad20230—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+6K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+6K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+7K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+7K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K241470CORE Shoulder SystemLinkBio Corp.202501
+7K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—