510(k) Report

Devices descending from K030377

391 later devices reach Modification to Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+1K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+1K113346Neon SystemUlrich GmbH & Co. KG20121—
+1K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign)20092—
+1K070573Synapse SystemSynthes Spine Co.Lp2007378—
+2K230614Cortium™Ulrich Medical USA20230—
+2K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+2K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+2K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K171881JAZZ Passer BandImplanet, S.A.20170—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K153759SIGN Compression Screw SystemSign Fracture Care International20160—
+2K152757SIGN Hip Construct (SHC)Sign Fracture Care International20150—
+2K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+2K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K100634Synthes Matrix SystemSynthes (Usa)2010316—
+2K090343Sentinel Spinal SystemLife Spine200921—
+2K090549Synthes Synapse TransconnectorSynthes Spine20091—
+2K072434Synthes OC Fusion and Synapse SystemsSynthes Spine Co.Lp20082—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+3K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K120998Solstice Cross ConnectorLife Spine20121—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K113149Synthes Uss ConnectorsSynthes Spine201293—
+3K113654CaspianK2m, Inc.201244—
+3K113044Synthes MirsSynthes Spine2011933
+3K111358Synthes UssSynthes Spine2011151—
+3K103232Caspian Spinal SystemK2m, Inc.201146—
+3K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K223852VySpan™ PCT SystemVy Spine, LLC20231—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K193129Yukon OCT Spinal SystemK2m, Inc.202001
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K173047The Solstice OCT SystemLife Spine, Inc.20180—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123134Easyspine SystemLdr Spine USA, Inc.20131—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232167VySpan™ PCT SystemVy Spine, LLC20230—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—