510(k) Report

Devices descending from K090707

281 later devices reach Talos Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K230583Tryptik TiSpineart SA20231—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+5K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+5K182349Concorde LiftMedos International SARL20190—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173537Concorde Lift™Medos International SARL20181—
+6K261049Scala® TLSpineart SA20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—