510(k) Report

Devices descending from K160125

315 later devices reach Cascadia Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+1K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+1K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+1K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+1K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+1K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+1K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+1K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+1K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+1K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+1K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+1K182477Cervical SpacerAdditive Implants, LLC201915—
+1K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+1K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+1K171312FortiCore®Nanovis, LLC20183—
+1K171140Matrixx SystemNexxt Spine, LLC2017145—
+1K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+1K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+1K170055CAPRI Corpectomy Cage SystemK2m201711—
+1K163364MOJAVE Expandable Interbody SystemK2m201725—
+1K162264Cascadia Interbody SystemK2m, Inc.2016169—
+2K261049Scala® TLSpineart SA20260—
+2K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+2K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+2K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+2K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+2K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+2K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+2K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+2K210359Hexanium TLIFSpinevision, S.A.S.20211—
+2K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+2K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+2K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+2K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+2K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K172009Cascadia Interbody SystemK2m, Inc.2017433
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K171704CAPRI Corpectomy Cage SystemK2m201710—
+2K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+3K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+3K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+3K223251Hexanium PLIFSpinevision, S.A.S.20220—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—