510(k) Report

Devices descending from K031511

902 later devices reach Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K132878M.U.S.T. ExtensionMedacta International201328—
+5K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132303Implanet Spine SystemImplanet, S.A.201315—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+5K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+5K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—