510(k) Report

Devices descending from K090230

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—