510(k) Report

Devices descending from K052151

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+1K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011348—
+1K100634Synthes Matrix SystemSynthes (Usa)2010316—
+1K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+1K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+1K070973Quantum Spinal SystemPioneer Surgical Technology2007178—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+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
+2K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+2K170654USS SystemSynthes USA Products, LLC201789—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120571Synthes Uss ConnectorSynthes Spine201274—
+2K113361Securis Spinal FixationCumtom Spine20120—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K113149Synthes Uss ConnectorsSynthes Spine201293—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K113044Synthes MirsSynthes Spine2011933
+2K111358Synthes UssSynthes Spine2011151—
+2K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090—
+2K100952Modification to Synthes Matrix SystemSynthes Spine2010314Class I
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+2K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008174—
+2K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology200892—
+2K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology2007177—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K141850Flospine Pedicle Screw SystemFlospine20140—