510(k) Report

Devices descending from K112316

537 later devices reach 4-Web Alif Spinal Truss System (STS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K230026SqualeImplanet, S.A.20230—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—