510(k) Report

Devices descending from K073364

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+1K130877Expedium Spine SystemMedos International SARL20138—
+1K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+1K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+1K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+1K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+1K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+1K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+2K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+2K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+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—
+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—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K113044Synthes MirsSynthes Spine2011933
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+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
+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
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K100757Tilock Pedicle Screw SystemGenesys Spine201091
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+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—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+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—
+3K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+3K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—