510(k) Report

Devices descending from K081297

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2009146—
+1K083071Vertex Reconstruction SystemMedtronic Sofamor Danek20082231
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+2K123906Vertex Reconstruction System, Vertext Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201322—
+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—
+2K123568Vertex Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20120—
+2K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc.201223—
+2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+3K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K140734Nextgen Altius Oct SystemEbi, LLC20140—
+3K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+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—
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K152211PCT SystemCentinel Spine, Inc.20150—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233366SYMPHONY OCT SystemMedos International SARL20230—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—