510(k) Report

Devices descending from K981714

597 later devices reach Timx Low Back System Titanium MX Rod Based Low Back System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K010576Monarch Spine SystemDepuyacromed2001596—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+2K062513Apex Spine SystemSpinecraft, Inc.2006179—
+2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+2K032604Gii Spinal Fixation SystemCo-Ligne AG20045—
+2K024348Monarch Spine SystemDepuyacromed2003578—
+2K023438Modification to Monarch Spine SystemDepuyacromed20024—
+2K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed2002496—
+2K013441Isola Polyaxial WasherDepuyacromed2001262—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K173508Everest Spinal SystemK2m20189—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100757Tilock Pedicle Screw SystemGenesys Spine201091
+3K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+3K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+3K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+3K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+3K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+3K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+3K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+3K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+3K051089Gii Spinal Fixation SystemCo-Ligne AG20054—
+3K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243249TriALTIS™ Spine SystemMedos International SARL20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—