510(k) Report

Devices descending from K020279

693 later devices reach Forex Corporation, Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K2024984CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited20213—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+3K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K181824CBT Screw Fixation SystemU&I Corporation20180—
+3K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+3K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+3K153152Syzygy Stabilization SystemAmendia, Inc.201602
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122931S-Lok PSS SystemSpinal USA20120—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc.20124—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+3K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd.20112—
+3K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090—
+3K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology20108—
+3K100765Fixpine II SystemDio Medical Co., Ltd.201023—
+3K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+3K100575LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA20107—
+3K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+3K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+3K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+3K092128Modification to: PSS SystemSpinal USA200936—
+3K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+3K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+3K090033Modification to: PSS SystemSpinal USA200937—
+3K082509Eos Spinal SystemKorea Bone Bank Co., Ltd.2008140—
+3K0824534CIS Solar and Apollon Spine SystemsSolco Biomedical Co., Ltd.2008126—
+3K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+3K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+3K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+3K081296Preference Pedicle Screw SystemUs Spine20083—
+3K080876DVX Spine SystemBk Meditech, Co., Ltd.20081—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073240PSS SystemSpinal USA200836—