510(k) Report

Devices descending from K052123

774 later devices reach Synthes Pangea System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153152Syzygy Stabilization SystemAmendia, Inc.201602
+1K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+1K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+1K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+1K120696Tiger Spine SystemCorelink, LLC201241—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K110655Mahe Perfect Spine- Pedicle Screw SystemMahe Medical GmbH20110—
+1K110906Apex Spine SystemSpinecraft, LLC2011103—
+1K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+1K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+1K092420KRD1 Pedicle Screw SystemSpinefrontier, Inc.200962
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K082914ClampfixSynthes Spine2008350—
+1K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+1K082572Uss Iliosacral, Uss PolyaxialSynthes Spine2008659—
+1K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+1K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+1K072685Ngarde SystemN Spine, Inc.200709
+2K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K203023Pisces Spinal SystemOrtho Development Corporation20210—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+2K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+2K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+2K170654USS SystemSynthes USA Products, LLC201789—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K151977icotec Pedicle SystemIcotec AG201630—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K143110GALAXY MIS Screw SystemBm Korea20152—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150185Mont Blanc Spinal SystemSpineway20154—
+2K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K113361Securis Spinal FixationCumtom Spine20120—
+2K113058Tiger Spine SystemCorelink, LLC201281—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+2K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+2K113044Synthes MirsSynthes Spine2011933
+2K110633Lancer Pedicle Screw SystemSpinal Solutions, LLC201108
+2K111358Synthes UssSynthes Spine2011151—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+2K100634Synthes Matrix SystemSynthes (Usa)2010316—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+2K090605ClampfixSynthes (Usa)2009349—
+2K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+2K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—