510(k) Report

Devices descending from K071668

582 later devices reach Orthobiom Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173508Everest Spinal SystemK2m20189—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170647Connector SystemOrthofix, Inc.201718—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162764Jazz Frame SystemImplanet, S.A.20176—
+3K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+3K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K133402K2M Modular HooksK2m, Inc.20140—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+3K132395LigapassMedicrea International201323—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K132287Jazz SystemHogan Lovells US LLP201315—
+3K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121541Jazz SystemImplanet, S.A.201227—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K113044Synthes MirsSynthes Spine2011933
+3K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—