510(k) Report

Devices descending from K160125

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K203003Pantheon IBFDPantheon Spinal20210—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202637F3D Corpectomy SystemCorelink, LLC20201—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—