510(k) Report

Devices descending from K010742

272 later devices reach Moss Miami 5.5MM Titanium Pin Nut through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+1K023804Moss Miami Spinal System Pin NutDepuyacromed2003265—
+2K110551Expedium Spine SystemJohnson & Johnson20111—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K101070Expedium Spine SystemMedos International SARL20102601
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K173508Everest Spinal SystemK2m20189—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—