510(k) Report

Devices descending from K041801

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+1K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+1K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+1K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+1K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+1K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc.20101—
+1K100757Tilock Pedicle Screw SystemGenesys Spine201091
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+1K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+1K071860Modification to: Viper Spine SystemDepuy Spine, Inc.2007423—
+1K061520Viper Spine SystemDepuy Spine, Inc.2006517—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+2K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+2K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+2K143110GALAXY MIS Screw SystemBm Korea20152—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140219Picasso II Mis Spinal SystemAccel Spine20141—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K121728Tiger Spine SystemCorelink, LLC201250—
+2K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+2K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K113044Synthes MirsSynthes Spine2011933
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K111571Viper SystemsJohnson & Johnson2011203—
+2K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+2K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K100605Mis SystemSpine Wave, Inc.201033—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K061813Mantis Spinal SystemStryker Spine20061352
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K252322SIros-X SystemGenesys Spine20250—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—