510(k) Report

Devices descending from K052187

780 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K181397DualXInnovasive, Inc.201815—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K142381Xia 3 Spinal SystemStryker Corp.201483—
+5K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—