510(k) Report

Devices descending from K022778

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+8K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+8K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+8K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+8K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+8K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+8K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+8K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+8K200303Reform Pedicle Screw SystemPrecision Spine202010—
+8K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+8K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+8K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+8K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+8K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+8K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+8K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K190376PASS LP Spinal SystemMedicrea International SA201915
+8K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+8K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+8K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+8K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+8K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+8K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+8K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+8K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+8K180433Ennovate®Aesculap Implant Systems, LLC201811
+8K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+8K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173126Arisstos™ Spinal SystemIngenium Spine20171—
+8K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+8K171651Excelsius GPSGlobus Medical, Inc.2017691
+8K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+8K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162764Jazz Frame SystemImplanet, S.A.20176—
+8K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+8K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+8K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+8K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+8K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+8K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+8K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+8K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+8K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+8K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+8K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+8K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+8K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+8K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+8K142499Reline SystemNu Vasive, Incorporated201478—
+8K142381Xia 3 Spinal SystemStryker Corp.201483—
+8K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+8K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+9K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+9K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+9K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K253249TriALTIS™ Spine SystemMedos International SARL20251—
+9K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—