510(k) Report

Devices descending from K053115

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K150449LITe Plate SystemStryker Corp.201524—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K131533Cayman MI Plate SystemK2m, Inc.201372—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+4K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+4K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K103292Trio Trauma Spinal SystemStryker Corporation201185—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+4K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+4K101070Expedium Spine SystemMedos International SARL20102601
+4K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+4K101144Modification to:Radius Spinal SystemStryker Spine201090—
+4K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K090320Conquest Spinal SystemLife Spine20092—
+4K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—