510(k) Report

Devices descending from K090230

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+1K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K130877Expedium Spine SystemMedos International SARL20138—
+1K122877Range Spinal System, Small StatureK2m, Inc.201334—
+1K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+1K110551Expedium Spine SystemJohnson & Johnson20111—
+1K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+1K101070Expedium Spine SystemMedos International SARL20102601
+1K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+1K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+1K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+2K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+2K173508Everest Spinal SystemK2m20189—
+2K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+2K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+2K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+2K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+2K143350Nile Alternative FixationK2m, Inc.201510—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131784Range Spinal SystemK2m, Inc.201334—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K131343Reform Pedicle Screw SystemSpinal USA201331—
+2K130279Reform Pedicle Screw SystemSpinal USA201331—
+2K131030Range Spinal SystemK2m, Inc.201334—
+2K130330Range Spinal SystemK2m, Inc.201336—
+2K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+2K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K120564Calypso SystemHogan Lovells US LLP201216—
+2K121020Viper SystemDepuy Spine, Inc.201294—
+2K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+2K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+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—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—