510(k) Report

Devices descending from K011182

711 later devices reach Modified Moss Miami 4.35MM Diameter Polyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+4K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+4K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+4K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K100605Mis SystemSpine Wave, Inc.201033—
+4K090320Conquest Spinal SystemLife Spine20092—
+4K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411