510(k) Report

Devices descending from K063156

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133369Tiger Spine SystemCorelink, LLC201429—
+1K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+1K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+1K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+1K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+1K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+1K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+1K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+1K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+1K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+1K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+2K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+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—
+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—
+2K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+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—
+2K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K111571Viper SystemsJohnson & Johnson2011203—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+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—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., 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
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+3K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+3K173508Everest Spinal SystemK2m20189—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K121728Tiger Spine SystemCorelink, LLC201250—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K120696Tiger Spine SystemCorelink, LLC201241—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—