510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+6K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+6K131077Life Spine Plateau Spacer SystemLife Spine201310—
+6K131671MectalifMedacta International201322—
+6K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+6K123388K7C SpacerK7, LLC20130—
+6K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+6K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+6K122047Alamo PAlliance Partners, LLC20120—
+6K122444Cervical CageEisertech, LLC201222—
+6K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+6K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+6K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+6K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+6K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+6K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+6K113478Plif CageEisertech, LLC2012269—
+6K113138Aleutian SystemK2m, Inc.2012549—
+6K112664Zavation Ibf SystemsZavation, LLC201137—
+6K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+6K112862Mecta-CMedacta International201114—
+6K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+6K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+6K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+6K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+6K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+6K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+6K111569Plateau Spacer SystemLife Spine2011181—
+6K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+6K110927MectalifMedacta International2011301
+6K103111Forza Spacer SystemOrthofix, Inc.20113431
+6K103169AleuttianK2m, Inc.2011572—
+6K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+6K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+6K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+6K101302Aleutian Ibf SystemK2m, Inc.2010595—
+6K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+6K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+6K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+6K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+6K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+6K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+6K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+6K082801Phantom Plus Cage SystemUs Spine2008643—
+6K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+6K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+6K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+6K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+6K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+6K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K261408SABER-XA SystemElevation Spine20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K243670Idys® LIFClariance20240—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—