510(k) Report

Devices descending from K121151

116 later devices reach Pro-Link Cervical Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+1K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+1K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+1K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+1K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K240715Idys® C ZP 3DTiClariance20240—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+2K212562Idys-C ZP 3DTiClariance, SA20211—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+2K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K230026SqualeImplanet, S.A.20230—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—