510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+5K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132603Apex Spine SystemSpinecraft, LLC201325—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K130176Firebird Spinal Fixation SystemOrthofix20135—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K121630Range Spinal SystemK2m, Inc.2012127—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+5K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+5K100605Mis SystemSpine Wave, Inc.201033—
+5K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521