510(k) Report

Devices descending from K162264

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+1K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+1K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+1K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+1K172941CASCADIA Interbody SystemK2m201852—
+1K172009Cascadia Interbody SystemK2m, Inc.2017433
+1K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+2K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+2K221172FOCUS Interbody SystemOc Medical Devices20220—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+2K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—