510(k) Report

Devices descending from K944736

598 later devices reach VSP (Variable Screw Placement) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+5K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+5K120469Erisma-LPClariance20126—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+5K120899Range Spinal System, Unit RodK2m, Inc.201235—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K110551Expedium Spine SystemJohnson & Johnson20111—
+5K103671Genesys Spine Tilock SystemGenesys Spine20118—
+5K111571Viper SystemsJohnson & Johnson2011203—
+5K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+5K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+5K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+5K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—