510(k) Report

Devices descending from K021705

330 later devices reach Modification to Townley Transfacepedicular Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131417Facet FixxNexxt Spine, LLC2013130—
+1K062254Axis Fixation SystemMedtronic Sofamor Danek, Inc.2008222—
+2K180729FaSet Fixation SystemHuvexel Co., Ltd.20183—
+2K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.201718—
+2K143471VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2015165—
+2K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC20151921
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc.20239—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K230297PMT Expandable Cage (PMT EXP)Providence Medical Technology, Inc.20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K222515FaSet Fixation SystemDio Medical Corporation20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K211855Ion Facet Screw SystemSurGenTec, LLC202210—
+3K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K181949SYMPHONY™ OCT SystemMedos International SARL201810—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K171834G Surgical OCT Spinal SystemG Surgical, LLC20170—
+3K172594Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.201712—
+3K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K170804The Solstice OCT SystemLife Spine, Inc.20173—
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K162639Proficient™ Posterior Cervical Spine SystemSpine Wave, Inc.201713—
+3K161637Poseidon OCT Spinal Fixation SystemMedyssey USA, Inc.20170—
+3K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+3K161149PASS OCT Spinal SystemMedicrea International SA20160—
+3K160697Gibralt® Spine System and Gibralt® Occipital Spine SystemExactech, Inc.20165—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160756PASS OCT Spinal SystemMedicrea International SA20160—
+3K153386Perla Posterior Cervico-Thoracic Fixation systemSpineart20162—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K152338VERTEX (r) Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201534—
+3K151938S4 Cervical Spinal and Occiput SystemsAesculap Implant Systems, LLC20152—
+3K150474NuVasive VuePoint II OCT SystemNu Vasive, Incorporated201526—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—
+3K150650neon3Ulrich GmbH & Co. KG2015101
+3K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc.201541—
+3K151705Lotus Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20150—
+3K151224Lineum OCT Spine SystemBiomet Spine2015231
+3K151031Virage OCT Spinal Fixation SystemZimmer Spine, Inc.201520—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K150570ANAX OCT Spinal SystemU&I Corporation20152—
+3K150822Centurion POCT SystemOrthofix, Inc.201523—
+3K150539OASYS SystemStryker Corporation201534—
+4K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+4K261209Ion-LSurGenTec, LLC20260—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K251714Ion-CSurGenTec, LLC20260—
+4K253190CORUS-LX ImplantProvidence Medical Technology, Inc.20250—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252153FFX Facet Fixation SystemSc Medica20252—
+4K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.20251—
+4K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+4K243865AERO MIS Facet Fusion SystemAurora Spine20250—
+4K243265Ion 3DSurGenTec, LLC20241—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K232468SC Medica FFXSc Medica20243—
+4K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K240086Ion 3DSurGenTec, LLC20243—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K230614Cortium™Ulrich Medical USA20230—
+4K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+4K220658COSY Cervicothoracic Occipital Rod-Screw SystemSignus Medizintechnik GmbH20220—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K213871Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC20220—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—