510(k) Report

Devices descending from K042453

898 later devices reach Modification to Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+6K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K142381Xia 3 Spinal SystemStryker Corp.201483—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+6K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+6K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—