510(k) Report

Devices descending from K033849

379 later devices reach Simplant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20197—
+4K1730413DIEMME RealGUIDE3Diemme, Ltd.20182—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K180629DentiqGuide3D Industrial Imaging Co., Ltd.20181—
+4K173970Materialise PKA Guide SystemMaterialise NV20185—
+4K170793SuRgical Planner (SRP)Surgical Theater, LLC201851
+4K173445Materialise TKA Guide SystemMaterialise NV201891
+4K170849SIMPLANT GuideDentsply Sirona20172—
+4K162799CliniviewPalodex Group OY201713—
+4K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV20178—
+4K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+4K162273Materialise TKA Guide SystemMaterialise NV201611—
+4K151285VSP Cranial System3D Systems, Inc.20160—
+4K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+4K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+4K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+4K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+4K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K142107Echo True 3D ViewerEchopixel, Inc.2015271
+4K142048Emprint Procedure Planning ApplicationCovidien, LLC20143—
+4K140819Surgical Navigation Advanced PlatformSurgical Theater, LLC20141—
+4K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+4K133162Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…Materialise NV201413—
+4K131409Cas Psi Knee SystemOrthosoft, Inc.201321
+4K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+5K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+5K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.20260—
+5K253944Data Analysis Facilitation Suite (DAFS)Voronoi Health Analytics Incorporated20260—
+5K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+5K250023Smart PCFDDisior, Ltd.20250—
+5K243509Archer PSI System3D-Side20250—
+5K243069Lumys (V1)Intradys20250—
+5K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV20251—
+5K241470CORE Shoulder SystemLinkBio Corp.202501
+5K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.20240—
+5K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+5K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+5K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics20242—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K233874tmCMF SolutionTechmah Cmf20240—
+5K240736SMART Bun-Yo-Matic X-RayDisior, Ltd.20240—
+5K240642SMART Bun-Yo-Matic CTDisior, Ltd.20242—
+5K232841Axial3D InsightAxial Medical Printing Limited20231—
+5K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics20233—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+5K230044Pre-SureLazarus 3D20230—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K220366EmbedMed3D Lifeprints UK, Ltd.20220—
+5K220648OMF ASP SystemVha Dean20220—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K221337Materialise TKA Guide SystemMaterialise NV202221
+5K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC20223—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K213302exoplanExocad GmbH202201
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+5K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter…Zirkonzahn Srl20210—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K210347VSP System3D Systems20211—
+5K203156DTX Studio ClinicNobel Biocare AB202010—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K202207Materialise PKA Guide SystemMaterialise NV20200—
+5K193405Simplant Digital GuideDentsply Sirona20200—
+5K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20200—
+5K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K201465SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.202041
+5K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20202—
+5K190059CEREC GuidesDentsply Sirona20190—
+5K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+5K190074Presero 3D Scanning SystemCertis Health20190—
+5K180192Emprint Ablation Visualization ApplicationCovidien, LLC20182—
+5K172224DTX Studio diagnoseNobel Biocare AB20180—
+5K171269X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20171—
+5K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+5K172650Materialise PKA Guide SystemMaterialise NV20176—
+5K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+5K171356Clarity RevealCeevra, Inc.201718—
+5K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+5K170167True 3D Viewer SoftwareEchopixel, Inc.201761
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+5K160584Surgical Navigation Advanced Platform (SNAP)Surgical Theater, LLC201604
+6K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+6K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV20260—
+6K250369Axial3D InsightAxial Medical Printing Limited20250—
+6K251554Materialise TKA Guide SystemMaterialise NV20251—
+6K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+6K241811MedCAD® AccuStride™ SystemMedcad20252—
+6K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics20251—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+6K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—