510(k) Report

Devices descending from K012870

908 later devices reach Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+5K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+5K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+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—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+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—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+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
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001