510(k) Report

Devices descending from K984251

372 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K141397Sure-Lok C Extended Tab Pedicle Screw SystemPrecision Spine, Inc.20140—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+3K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+3K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+3K030369Opus Spinal SystemHowmedica Osteonics Corp.20030—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+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—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—