510(k) Report

Devices descending from K153495

189 later devices reach Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+1K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+1K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+1K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+1K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+2K261408SABER-XA SystemElevation Spine20260—
+2K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+2K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+2K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+2K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K172816TiGer Shark™ SystemChoicespine, LP201859—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+3K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+3K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—