510(k) Report

Devices descending from K031090

891 later devices reach Modification to Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+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—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+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—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+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—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+5K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+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—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+5K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+5K160362Z-Span Plate SystemZavation, LLC20163—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K141044M.U.S.T. ExtensionMedacta International201416—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132878M.U.S.T. ExtensionMedacta International201328—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K130877Expedium Spine SystemMedos International SARL20138—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+5K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+5K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+5K110551Expedium Spine SystemJohnson & Johnson20111—
+5K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+5K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+5K101070Expedium Spine SystemMedos International SARL20102601
+5K101144Modification to:Radius Spinal SystemStryker Spine201090—
+5K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+5K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+5K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+5K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+5K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+5K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521