510(k) Report

Devices descending from K022949

867 later devices reach Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+1K132575Pass LP Spinal SystemMedicrea International20130—
+1K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+1K131030Range Spinal SystemK2m, Inc.201334—
+1K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+1K121568Dali Spinal Fixation SystemAccel Spine20121—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+1K120899Range Spinal System, Unit RodK2m, Inc.201235—
+1K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+1K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K090605ClampfixSynthes (Usa)2009349—
+1K082914ClampfixSynthes Spine2008350—
+1K082572Uss Iliosacral, Uss PolyaxialSynthes Spine2008659—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+1K061321Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XXAlphatec Spine, Inc.20060—
+1K040442Protex Stabilization SystemGlobus Medical, Inc.2004551—
+1K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041801
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.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—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+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—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+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—
+2K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+2K200303Reform Pedicle Screw SystemPrecision Spine202010—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+2K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K170654USS SystemSynthes USA Products, LLC201789—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+2K151974Polaris Spinal SystemBiomet Spine201516—
+2K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K113044Synthes MirsSynthes Spine2011933
+2K111358Synthes UssSynthes Spine2011151—
+2K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+2K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+2K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+2K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+2K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+2K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+2K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+2K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+2K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+2K061202Revere Stabilization SystemGlobus Medical, Inc.2006547—
+2K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005549—
+2K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176—
+2K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—