510(k) Report

Devices descending from K982987

226 later devices reach Synthes Posterior Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K062136Pass 2 Spinal SystemMedicrea2006146—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K121979Pass Oct Spinal SystemMedicrea International201314—
+2K112493Pass LP Spinal SystemMedicrea International20111—
+2K110497Pass LP Spinal SystemMedicrea International20111331
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K153413PASS LP Spinal SystemMedicrea International SA20160—
+3K150918PASS OCT Spinal SystemMedicrea International SA201513—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K123138Pass LP Spinal SystemMedicrea International2013132—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K142798PASS LP Spinal SystemMedicrea International SA201584—
+4K150049PASS LP Spinal SystemMedicrea International20150—
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K140738Pass LP Spinal SystemMedicrea International201447—
+4K132574Pass LP Spinal SystemMedicrea International20130—
+4K132575Pass LP Spinal SystemMedicrea International20130—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—