510(k) Report

Devices descending from K052123

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson201401
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K130176Firebird Spinal Fixation SystemOrthofix20135—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+3K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+3K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+3K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+3K080767Conquest Spinal SystemLife Spine200821—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+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—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+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—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+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—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+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—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—