510(k) Report

Devices descending from K073449

143 later devices reach Surgicase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+1K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+1K112389Surgicase Connect, Surgicase GuideMaterialise NV201259—
+1K111863Signature Planner,Signature GuidesMaterialise NV201271—
+1K113599Surgicase ConnectMaterialise NV20124—
+1K111641Surgicase Orthognathic Software WizardMaterialise NV20116—
+1K102795Signature Planner; Signature GuidesMaterialise NV2011994
+2K223427Mimics Enlight CMFMaterialise NV20240—
+2K190767AnatomicAlignerThe Methodist Hospital Research Institute D/B/A Houston20200—
+2K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+2K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+2K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+2K170419SurgiCase ViewerMaterialise NV20173—
+2K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+2K161634IPS CaseDesignerNobel Biocare AB20163—
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+2K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+2K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesMaterialise NV201512—
+2K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+2K132290Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV201418—
+2K140257Signature Planner, Signature GuidesMaterialise NV20140—
+2K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+2K131129Cas Psi ShoulderZimmer Cas201339—
+2K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+2K121640Zimmer Patient Specific Instruments SystemMaterialise NV2012601
+2K113829Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…Materialise NV201213—
+2K110415Signature Planner / Signature GuidesMaterialise NV2011131
+3K260116CustoMED ViewerCustoMED, Ltd.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+3K213684SurgiCase ViewerMaterialise NV20221—
+3K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+3K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K200810IPS CaseDesignerNobel Biocare AB20201—
+3K202484Cordera Hip SystemConformis, Inc.202022
+3K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K192198Conformis Hip SystemConformis, Inc.2019121
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K173970Materialise PKA Guide SystemMaterialise NV20185—
+3K173445Materialise TKA Guide SystemMaterialise NV201891
+3K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+3K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV20178—
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K162273Materialise TKA Guide SystemMaterialise NV201611—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+3K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+3K150730Zimmer PSI Shoulder SystemZimmer201511—
+3K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+3K133162Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…Materialise NV201413—
+3K131409Cas Psi Knee SystemOrthosoft, Inc.201321
+3K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+4K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+4K243509Archer PSI System3D-Side20250—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics20242—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics20233—
+4K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+4K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+4K231178ACTERA™ hip systemConformis, Inc.20230—
+4K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K221337Materialise TKA Guide SystemMaterialise NV202221
+4K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC20223—
+4K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+4K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+4K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+4K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K202207Materialise PKA Guide SystemMaterialise NV20200—
+4K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+4K171269X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20171—
+4K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K172650Materialise PKA Guide SystemMaterialise NV20176—
+4K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+4K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K251554Materialise TKA Guide SystemMaterialise NV20251—
+5K241811MedCAD® AccuStride™ SystemMedcad20252—
+5K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics20251—
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+5K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+5K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—