510(k) Report

Devices descending from K030197

193 later devices reach Blackstone Posterior Cervical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+1K152211PCT SystemCentinel Spine, Inc.20150—
+1K131833Centurion Poct SystemOrthofix, Inc.20142—
+1K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+1K101084Caspian Spinal SystemK2m, Inc.201062—
+1K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+1K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc.2008124—
+1K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+1K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc.2008129—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K042100Blackstone Ascent Poct System 5.5MM/3.0MM Single Axial ConnectorBlackstone Medical, Inc.2004139—
+1K033980Blackstone Ascent Poct System Hooks (System Modification)Blackstone Medical, Inc.2004134—
+2K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+2K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+2K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+2K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+2K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K170647Connector SystemOrthofix, Inc.201718—
+2K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+2K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K141284Caspian Spinal SystemK2m, Inc.20140—
+2K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K113346Neon SystemUlrich GmbH & Co. KG20121—
+2K113654CaspianK2m, Inc.201244—
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K103232Caspian Spinal SystemK2m, Inc.201146—
+2K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+2K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+3K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+3K230614Cortium™Ulrich Medical USA20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K172194Connector SystemOrthofix, Inc.2017162
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+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—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.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—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+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—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200896Solstice CCILife Spine, Inc.20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190751Connector SystemOrthofix, Inc.20193—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—