510(k) Report

Devices descending from K853033

696 later devices reach Hartshill Rect & Wires, Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+5K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+5K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173047The Solstice OCT SystemLife Spine, Inc.20180—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+5K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170647Connector SystemOrthofix, Inc.201718—
+5K162575Z-LINKPC SystemZavation, LLC20173—
+5K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+5K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+5K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+5K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+5K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+5K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+5K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K140734Nextgen Altius Oct SystemEbi, LLC20140—
+5K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+5K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+5K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+5K130877Expedium Spine SystemMedos International SARL20138—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K120998Solstice Cross ConnectorLife Spine20121—
+5K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+5K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+5K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K113346Neon SystemUlrich GmbH & Co. KG20121—
+5K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+5K111719Oasys Spinal SystemStryker Spine201239—
+5K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+5K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+5K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+5K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+5K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+5K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+5K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+5K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+5K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+5K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+5K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+5K101183Modification to: Oasys SystemStryker Spine20100—
+5K101070Expedium Spine SystemMedos International SARL20102601
+5K093670Modification to: Oasys SystemStryker Spine201041Class I
+5K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+5K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+5K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+5K090549Synthes Synapse TransconnectorSynthes Spine20091—
+5K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+5K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+5K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+5K080143Modification to Stryker Spine Oasys SystemStryker Spine200843—
+5K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+5K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+5K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+5K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+5K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+5K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—