510(k) Report

Devices descending from K041801

533 later devices reach Expedium Mis Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+6K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K223294SpineJack® Expansion KitStryker Instruments20221—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250637VCFix Spinal SystemAmber Implants20250—
+8K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—