510(k) Report

Devices descending from K042789

325 later devices reach Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+1K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc.201223—
+1K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+1K090714Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek2009233—
+1K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2009146—
+1K083071Vertex Reconstruction SystemMedtronic Sofamor Danek20082231
+1K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+1K053483Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2006262—
+1K052180Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2005187—
+1K050979S4 Spinal SystemAesculap, Inc.200567—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+2K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+2K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+2K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+2K133214Blackbird Spinal SystemChoicespine, LP20143—
+2K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+2K123906Vertex Reconstruction System, Vertext Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201322—
+2K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+2K123568Vertex Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20120—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+2K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+2K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+2K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+2K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+2K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+2K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+2K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+2K062934SierraSeaspine, Inc.200621—
+2K060683Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200632—
+2K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+2K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005175—
+3K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+3K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—
+3K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+3K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133698Synapse SystemSynthes USA Products, LLC20146—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K121979Pass Oct Spinal SystemMedicrea International201314—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+3K120998Solstice Cross ConnectorLife Spine20121—
+3K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+3K113346Neon SystemUlrich GmbH & Co. KG20121—
+3K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+3K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+3K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+3K072729SierraSeaspine, Inc.20085—
+3K080526Sierra SystemSeaspine, Inc.20089—
+3K071942Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek200724—
+3K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200731—
+3K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2006151—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—