510(k) Report

Devices descending from K052151

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+3K130176Firebird Spinal Fixation SystemOrthofix20135—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+3K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology20108—
+3K100297Pass LP Spinal SystemMedicrea Technologies2010136—
+3K081296Preference Pedicle Screw SystemUs Spine20083—
+3K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K240963Spinal SystemTeslake, Inc.20240—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+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—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173508Everest Spinal SystemK2m20189—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—