510(k) Report

Devices descending from K082942

518 later devices reach Modfication to: Expedium Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—