510(k) Report

Devices descending from K120570

322 later devices reach Choice Spine Vertebral Body Replacement (VBR) Device System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+1K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+1K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+2K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K133967Interbody Cage SystemAurora Spine2014227—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K230026SqualeImplanet, S.A.20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K202637F3D Corpectomy SystemCorelink, LLC20201—
+3K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K192897icotec Cervical CageIcotec AG20201—
+3K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K242303MOD-COrthomod, LLC20260—