510(k) Report

Devices descending from K080313

397 later devices reach Modification to Expedium Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133369Tiger Spine SystemCorelink, LLC201429—
+1K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+1K111571Viper SystemsJohnson & Johnson2011203—
+1K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+1K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+1K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+1K101070Expedium Spine SystemMedos International SARL20102601
+2K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K193219G Surgical Marksman SystemG Surgical, LLC20191—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K173508Everest Spinal SystemK2m20189—
+2K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+2K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+2K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K121728Tiger Spine SystemCorelink, LLC201250—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K121020Viper SystemDepuy Spine, Inc.201294—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—