510(k) Report

Devices descending from K070573

378 later devices reach Synapse System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+1K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+1K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+1K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+1K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+1K101084Caspian Spinal SystemK2m, Inc.201062—
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K090343Sentinel Spinal SystemLife Spine200921—
+1K090549Synthes Synapse TransconnectorSynthes Spine20091—
+1K072434Synthes OC Fusion and Synapse SystemsSynthes Spine Co.Lp20082—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+2K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+2K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+2K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K141284Caspian Spinal SystemK2m, Inc.20140—
+2K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K120998Solstice Cross ConnectorLife Spine20121—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K113654CaspianK2m, Inc.201244—
+2K113044Synthes MirsSynthes Spine2011933
+2K111358Synthes UssSynthes Spine2011151—
+2K103232Caspian Spinal SystemK2m, Inc.201146—
+2K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K200896Solstice CCILife Spine, Inc.20200—
+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—
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K173047The Solstice OCT SystemLife Spine, Inc.20180—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—