510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+7K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181397DualXInnovasive, Inc.201815—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+7K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+7K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271