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
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K110551Expedium Spine SystemJohnson & Johnson20111—
+1K111571Viper SystemsJohnson & Johnson2011203—
+1K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+1K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+1K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+1K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008538—
+1K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+1K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company2007539—
+1K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+1K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+2K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+2K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K121728Tiger Spine SystemCorelink, LLC201250—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K121020Viper SystemDepuy Spine, Inc.201294—
+2K120696Tiger Spine SystemCorelink, LLC201241—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+2K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+2K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+2K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+2K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+2K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+2K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+2K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+2K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—