510(k) Report

Devices descending from K022778

670 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+7K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+7K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+7K180324Patriot Spinal Fixation SystemValorus Spine20180—
+7K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+7K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+7K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+7K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+7K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+7K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+7K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+7K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+7K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+7K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+7K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+7K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+7K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+7K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+7K141044M.U.S.T. ExtensionMedacta International201416—
+7K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+7K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+7K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+7K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+7K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+7K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+7K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+7K132878M.U.S.T. ExtensionMedacta International201328—
+7K132303Implanet Spine SystemImplanet, S.A.201315—
+7K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K240392JAZZ Spinal SystemImplanet20241—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+8K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—