510(k) Report

Devices descending from K082942

518 later devices reach Modfication to: 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—
+1K130877Expedium Spine SystemMedos International SARL20138—
+1K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+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—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+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—
+2K131343Reform Pedicle Screw SystemSpinal USA201331—
+2K130279Reform Pedicle Screw SystemSpinal USA201331—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K113044Synthes MirsSynthes Spine2011933
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+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—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+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—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173508Everest Spinal SystemK2m20189—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752