510(k) Report

Devices descending from K121683

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+10K230329F3D Interbody SystemCorelink, LLC20230—
+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
+10K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+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—
+10K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+10K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+10K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+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—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+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—
+11K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+11K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+11K223418DeGen Impulse AM™ SystemDegen Medical20236—
+11K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+11K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+11K212358Romero Cervical CageSpineup, Inc.20226—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K211306LabyrinthZavation Medical Products, LLC20213—
+11K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+12K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+12K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+12K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+12K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+12K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+12K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+12K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+12K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+12K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+12K230026SqualeImplanet, S.A.20230—
+13K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+13K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+13K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—