510(k) Report

Devices descending from K011029

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+8K173508Everest Spinal SystemK2m20189—
+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—
+8K171321K2M Navigation InstrumentsK2m201711
+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—
+8K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+8K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+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—
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+8K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+8K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+8K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+8K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+8K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+8K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+8K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+8K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+8K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+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—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+8K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+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—
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+8K132361Everest Spinal SystemK2m, Inc.201334—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+9K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+9K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+9K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253249TriALTIS™ Spine SystemMedos International SARL20251—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—
+9K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+9K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243249TriALTIS™ Spine SystemMedos International SARL20250—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+9K240160EGPS Navigated InstrumentsAstura Medical20240—
+9K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K241258Ingenix Spinal SystemIngenium Spine20240—
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K231515MySpine Cervical GuidesMedacta International S.A.20230—
+9K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+9K223558CUVIS-spineCurexo, Inc.20230—
+9K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+9K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—