510(k) Report

Devices descending from K003780

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+1K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+1K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+1K121979Pass Oct Spinal SystemMedicrea International201314—
+1K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC20124—
+1K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+1K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+1K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+1K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+1K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+1K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology201024—
+1K090714Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek2009233—
+1K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076—
+1K070638Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC200759—
+1K062934SierraSeaspine, Inc.200621—
+1K052376Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005254—
+1K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+1K042789Vertex Reconstruction SystemMedtronic Sofamor Danek2004325—
+1K042524Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2004373—
+1K042498Vertex Reconstruction SystemMedtronic Sofamor Danek20041881
+1K042402Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2004259—
+2K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+2K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+2K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+2K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+2K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+2K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+2K182182YUKON OCT Spinal SystemK2m20185—
+2K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K152211PCT SystemCentinel Spine, Inc.20150—
+2K150918PASS OCT Spinal SystemMedicrea International SA201513—
+2K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+2K133214Blackbird Spinal SystemChoicespine, LP20143—
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+2K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc.201223—
+2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+2K112757Pioneer Posterior Cervico Thoracic SystemPioneer Surgical Technology, Inc.2012181
+2K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20111—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K103040Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20112—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20095—
+2K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+2K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921—
+2K083073Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20098—
+2K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2009146—
+2K083071Vertex Reconstruction SystemMedtronic Sofamor Danek20082231
+2K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+2K080790Modification to Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC20089—
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+2K053483Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2006262—
+2K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005175—
+2K052180Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2005187—
+2K050979S4 Spinal SystemAesculap, Inc.200567—
+2K043020Glaxy 3.2 Spinal SystemMedtronic Sofamor Danek2005108—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K233366SYMPHONY OCT SystemMedos International SARL20230—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K223852VySpan™ PCT SystemVy Spine, LLC20231—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K210887Altus Spine Sochi OCT Spinal SystemAltus Partners, LLC20210—
+3K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+3K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—