510(k) Report

Devices descending from K150481

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+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—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223326Axiom PSR SystemRestor3D202301
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—