510(k) Report

Devices descending from K983583

965 later devices reach Depuy Acromed Moss and Moss Miami Spinal Systems 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—
+1K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+1K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+1K113361Securis Spinal FixationCumtom Spine20120—
+1K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+1K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+1K071743Pillar Pedicle Screw SystemThe 4th Column, LLC20070—
+1K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+1K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+1K024125Halm Zielke Instrumentation SystemMicomed Ortho GmbH20031—
+1K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+1K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002294—
+1K013294Monarch Spinal SystemsDepuyacromed20010—
+1K013295Timx Spinal SystemsDepuyacromed20010—
+1K013296Moss Miami Spinal SystemsDepuyacromed2001184—
+1K012971Isola Spinal SystemsDepuyacromed20012—
+1K010576Monarch Spine SystemDepuyacromed2001596—
+1K994347Centaur Spinal SystemHowmedica Osteonics Corp.2000343—
+1K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed1999547—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+2K193219G Surgical Marksman SystemG Surgical, LLC20191—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K182721Choice Spine Navigation SystemChoicespine, LP20192—
+2K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+2K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+2K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+2K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+2K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K150449LITe Plate SystemStryker Corp.201524—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K142699LITe Plate SystemStryker Corporation201446—
+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—
+2K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K113044Synthes MirsSynthes Spine2011933
+2K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K102406Pass Anterior Spinal SystemMedicrea Technologies20110—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K101070Expedium Spine SystemMedos International SARL20102601