510(k) Report

Devices descending from K153105

234 later devices reach MLX™ - Medial Lateral Expandable Lumbar Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230026SqualeImplanet, S.A.20230—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—