510(k) Report

Devices descending from K041119

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+1K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+1K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG20162—
+1K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K132878M.U.S.T. ExtensionMedacta International201328—
+1K130877Expedium Spine SystemMedos International SARL20138—
+1K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+1K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K113173Nanovis Spinal SystemNanovis, LLC20122—
+1K113044Synthes MirsSynthes Spine2011933
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+1K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+1K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008538—
+1K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+1K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+1K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+1K051024Expedium Spine SystemDepuy Spine, Inc.2005493—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K243249TriALTIS™ Spine SystemMedos International SARL20250—
+2K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K203452Nano FortiFix® SystemNanovis, LLC20200—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+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
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K081898Expedium Spine SystemDepuy Spine, Inc.200859—