510(k) Report

Devices descending from K032394

230 later devices reach Stryker Spine Oasys System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193129Yukon OCT Spinal SystemK2m, Inc.202001
+1K111719Oasys Spinal SystemStryker Spine201239—
+1K101183Modification to: Oasys SystemStryker Spine20100—
+1K093670Modification to: Oasys SystemStryker Spine201041Class I
+1K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology201024—
+1K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090—
+1K090343Sentinel Spinal SystemLife Spine200921—
+1K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+1K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K072568Modification to Oasys SystemStryker Spine200744—
+1K062853Modification to Stryker Spine Oasys SystemStryker Spine200653—
+1K052317Modification to: Stryker Spine Oasys SystemStryker Spine200561—
+1K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+2K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+2K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+2K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K142741OASYS SystemStryker Corporation201537—
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K112757Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc.2012181
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+2K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+2K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+3K200896Solstice CCILife Spine, Inc.20200—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K173047The Solstice OCT SystemLife Spine, Inc.20180—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150753OASYS SystemStryker Corporation201534—
+3K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+3K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+3K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+3K113346Neon SystemUlrich GmbH & Co. KG20121—
+3K113654CaspianK2m, Inc.201244—
+3K103232Caspian Spinal SystemK2m, Inc.201146—
+3K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K230614Cortium™Ulrich Medical USA20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223852VySpan™ PCT SystemVy Spine, LLC20231—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—