510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+5K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K223294SpineJack® Expansion KitStryker Instruments20221—
+5K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+5K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+5K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+5K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+5K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172267IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd.20180—
+5K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+5K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—