510(k) Report

Devices descending from K070754

506 later devices reach Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+1K103033Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-XxxxxZimmer Trabecular Metal Technology2011505—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K142041Porosteon Phusion Metal Cervical CagePorosteon, Inc.20141—
+2K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+2K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+2K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20124762
+2K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+2K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+3K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K172941CASCADIA Interbody SystemK2m201852—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K153621Juliet® TiSpineart2016751
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K261049Scala® TLSpineart SA20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—