510(k) Report

Devices descending from K021335

581 later devices reach Monarch Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+1K033512Procyon Spinal SystemNas Medical Technologies, Inc.20040—
+1K024348Monarch Spine SystemDepuyacromed2003578—
+1K023438Modification to Monarch Spine SystemDepuyacromed20024—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+2K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+2K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+2K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+2K062513Apex Spine SystemSpinecraft, Inc.2006179—
+2K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+3K243249TriALTIS™ Spine SystemMedos International SARL20250—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K173508Everest Spinal SystemK2m20189—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+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—
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K120469Erisma-LPClariance20126—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+3K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+3K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+3K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+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—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+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—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K153326Erisma-LP Spinal Fixation SystemClariance, Sas201651
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—