510(k) Report

Devices descending from K132029

108 later devices reach Vault-C Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240715Idys® C ZP 3DTiClariance20240—
+1K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+1K212562Idys-C ZP 3DTiClariance, SA20211—
+1K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+1K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+1K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+2K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+2K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+2K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+2K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+2K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+2K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+2K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+2K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+2K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+3K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221578Hexanium ACIFSpinevision, S.A.S.20224—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K230026SqualeImplanet, S.A.20230—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—