510(k) Report

Devices descending from K053115

889 later devices reach Xia Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+5K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+5K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K172941CASCADIA Interbody SystemK2m201852—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162367Erisma® LP MISClariance, Sas20162—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—