510(k) Report

Devices descending from K051454

666 later devices reach Aleutian Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—