510(k) Report

Devices descending from K080792

596 later devices reach K2M Cocr Rod through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K171582NEO Pedicle Screw System™Neo Medical SA20170—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+4K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—