510(k) Report

Devices descending from K131216

180 later devices reach Rampart O through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133371Rampart-LSpineology, Inc.20147—
+1K132053Rampart-O, Rampart-TSpineology, Inc.2013179—
+2K171724Rampart L Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+2K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+2K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+2K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+2K153082Rampart A Lumbar Interbody Fusion DeviceSpineology, Inc.201628—
+2K151020Rampart-T Interbody Fusion SystemSpineology, Inc.20151—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+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—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K171425Concorde LiftMedos International SARL201782
+5K261049Scala® TLSpineart SA20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+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—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173537Concorde Lift™Medos International SARL20181—
+6K261408SABER-XA SystemElevation Spine20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—