510(k) Report

Devices descending from K113465

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K182349Concorde LiftMedos International SARL20190—
+9K183092Kuros TLIF CageKuros Biosciences B.V20190—
+9K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+9K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+9K173537Concorde Lift™Medos International SARL20181—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K261067BEE PLIF CageNGMedical GmbH20260—
+10K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+10K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+10K221578Hexanium ACIFSpinevision, S.A.S.20224—
+10K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+10K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+10K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+10K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+10K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+10K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+10K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+10K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+10K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K211413BEE PLIF CageNGMedical GmbH20211—
+10K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+10K210728CONDUIT InstrumentsMedos International SARL20215—
+10K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+10K201287Impulse Interbody Fusion SystemDegen Medical20208—
+10K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+10K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+11K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+11K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+11K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+11K252742Navigated InstrumentsTyber Medical, LLC20251—
+11K252322SIros-X SystemGenesys Spine20250—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+11K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+11K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+11K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+11K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+11K223418DeGen Impulse AM™ SystemDegen Medical20236—
+11K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+11K212358Romero Cervical CageSpineup, Inc.20226—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—