510(k) Report

Devices descending from K090707

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+1K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+1K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K102957Cutting Edge Spine Interbody Fusion DeviceCutting Edge Spine, LLC201193—
+2K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+2K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+2K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+2K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+2K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+3K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+3K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+3K160631Keos Lumbar IBFDKeos20161—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200312Tryptik TiSpineart20202—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K193174Keos Lumbar IBFDKeos20190—
+4K191134IB3D AlifMedicrea International SA20191—
+4K1803473d CageFims Co., Ltd.20190—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K171425Concorde LiftMedos International SARL201782
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—