510(k) Report

Devices descending from K053115

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K190016Lateral Plate SystemCorelink, LLC201915—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+4K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561