510(k) Report

Devices descending from K011182

711 later devices reach Modified Moss Miami 4.35MM Diameter Polyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K173508Everest Spinal SystemK2m20189—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+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—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133103Aversion Pedicle Screw SystemK7, LLC20140—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+3K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+3K113044Synthes MirsSynthes Spine2011933
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+3K100757Tilock Pedicle Screw SystemGenesys Spine201091
+3K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+3K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+3K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+3K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—