510(k) Report

Devices descending from K990745

916 later devices reach Modification to Synthes Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+4K130655Response Spine SystemOrthoPediatrics Corp.201317—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+4K113666Xia 3 Spinal SystemStryker Spine2012251—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K121250OP Spine SystemOrthoPediatrics Corp.201218—
+4K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+4K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+4K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+4K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+4K111479Revere CrosstopGlobus Medical, Inc.2011232—
+4K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+4K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+4K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+4K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+4K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+4K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+4K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+4K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K100788Cocr RodsGlobus Medical, Inc.2010374—
+4K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+4K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+4K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+4K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+4K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+4K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+4K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+4K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+4K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+4K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+4K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—