510(k) Report

Devices descending from K113465

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172009Cascadia Interbody SystemK2m, Inc.2017433
+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—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+9K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+9K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+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—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K242589Scarlet® AL-TSpineart SA20240—
+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—
+9K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+9K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K234150Lucent® XPSpinal Elements20240—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+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—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223326Axiom PSR SystemRestor3D202301
+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—
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+9K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+9K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+9K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+9K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+9K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K200316UNiD IB3D ALIFMedicrea International SA20200—
+9K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+9K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+9K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+9K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+9K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—