510(k) Report

Devices descending from K091797

606 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+4K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—