510(k) Report

Devices descending from K123206

454 later devices reach Maxim Surgical X-Treme Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K223326Axiom PSR SystemRestor3D202301
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—