510(k) Report

Devices descending from K002858

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+6K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K141044M.U.S.T. ExtensionMedacta International201416—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132878M.U.S.T. ExtensionMedacta International201328—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K130877Expedium Spine SystemMedos International SARL20138—
+6K122877Range Spinal System, Small StatureK2m, Inc.201334—
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+6K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+6K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+6K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+6K110551Expedium Spine SystemJohnson & Johnson20111—
+6K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+6K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+6K101070Expedium Spine SystemMedos International SARL20102601
+6K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+6K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+6K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+6K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+7K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+7K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+7K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—