510(k) Report

Devices descending from K121683

682 later devices reach Acculif TL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K171425Concorde LiftMedos International SARL201782
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+9K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K242589Scarlet® AL-TSpineart SA20240—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+9K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+9K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+9K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K234150Lucent® XPSpinal Elements20240—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+9K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+9K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+9K223326Axiom PSR SystemRestor3D202301
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+9K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—