510(k) Report

Devices descending from K991089

678 later devices reach Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K231654NorthStar OCT SystemSeaspine, Inc.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+4K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+4K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K173047The Solstice OCT SystemLife Spine, Inc.20180—
+4K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+4K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170647Connector SystemOrthofix, Inc.201718—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+4K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+4K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+4K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K140734Nextgen Altius Oct SystemEbi, LLC20140—
+4K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K120998Solstice Cross ConnectorLife Spine20121—
+4K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+4K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+4K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113346Neon SystemUlrich GmbH & Co. KG20121—
+4K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+4K111719Oasys Spinal SystemStryker Spine201239—
+4K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+4K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+4K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+4K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+4K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+4K101183Modification to: Oasys SystemStryker Spine20100—
+4K101070Expedium Spine SystemMedos International SARL20102601
+4K093670Modification to: Oasys SystemStryker Spine201041Class I
+4K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+4K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+4K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+4K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+4K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+4K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+4K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+4K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—