510(k) Report

Devices descending from K070742

150 later devices reach Modification to 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
+1K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+1K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+1K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+1K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+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—
+2K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+2K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+2K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+2K140734Nextgen Altius Oct SystemEbi, LLC20140—
+2K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+2K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+2K113346Neon SystemUlrich GmbH & Co. KG20121—
+2K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K233366SYMPHONY OCT SystemMedos International SARL20230—
+3K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+3K230614Cortium™Ulrich Medical USA20230—
+3K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+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—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K152211PCT SystemCentinel Spine, Inc.20150—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—