510(k) Report

Devices descending from K031175

928 later devices reach Click'x Monoaxial Screws and Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K113361Securis Spinal FixationCumtom Spine20120—
+3K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+3K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+3K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+3K111479Revere CrosstopGlobus Medical, Inc.2011232—
+3K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+3K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+3K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+3K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+3K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+3K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology20108—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K100297Pass LP Spinal SystemMedicrea Technologies2010136—
+3K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+3K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+3K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+3K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+3K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+3K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+3K081296Preference Pedicle Screw SystemUs Spine20083—
+3K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812—
+3K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+3K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+3K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—