510(k) Report

Devices descending from K103033

505 later devices reach Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+1K173453Valeo® C+CSC with Lumen Interbody Fusion DeviceAmedica Corp.20180—
+1K142041Porosteon Phusion Metal Cervical CagePorosteon, Inc.20141—
+1K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+1K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+1K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20124762
+1K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+1K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+2K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+2K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+2K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+2K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+2K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K153621Juliet® TiSpineart2016751
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K261049Scala® TLSpineart SA20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—