510(k) Report

Devices descending from K981274

597 later devices reach Acromed Timx Plate Based Low Back System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+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—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+4K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K120469Erisma-LPClariance20126—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K120899Range Spinal System, Unit RodK2m, Inc.201235—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+4K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—