510(k) Report

Devices descending from K073291

1,103 later devices reach Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181397DualXInnovasive, Inc.201815—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K163180Hubble IIOrbbo Surgical, LLC20160—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K153400ProLift Expandable SystemLife Spine, Inc.201672—
+4K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+4K152304Tritanium PL CageStryker20154481
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+4K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+4K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+4K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+4K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+4K130194Acculif XL CageCoalign Innovations, Inc.20131—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—