510(k) Report

Devices descending from K071495

539 later devices reach Expedium 4.5MM Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+1K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+1K130877Expedium Spine SystemMedos International SARL20138—
+1K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+1K101070Expedium Spine SystemMedos International SARL20102601
+1K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+1K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+1K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008538—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+2K173508Everest Spinal SystemK2m20189—
+2K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+2K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+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—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121020Viper SystemDepuy Spine, Inc.201294—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K100757Tilock Pedicle Screw SystemGenesys Spine201091
+2K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+2K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133103Aversion Pedicle Screw SystemK7, LLC20140—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—