510(k) Report

Devices descending from K100952

314 later devices reach Modification to Synthes Matrix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+1K123134Easyspine SystemLdr Spine USA, Inc.20131—
+1K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+1K120838Synthes Matrix SystemSynthes Spine201216—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+1K120928Synthes Matrix SystemSynthes Spine20120—
+1K120571Synthes Uss ConnectorSynthes Spine201274—
+1K113149Synthes Uss ConnectorsSynthes Spine201293—
+1K113044Synthes MirsSynthes Spine2011933
+1K111358Synthes UssSynthes Spine2011151—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+2K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+2K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+2K190376PASS LP Spinal SystemMedicrea International SA201915
+2K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+2K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K141850Flospine Pedicle Screw SystemFlospine20140—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193