510(k) Report

Devices descending from K012870

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+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—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+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—
+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—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+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—
+5K172267IRENE Thoracolumbar Fixation SystemTianjin Zhengtian Medical Instrument Co., Ltd.20180—
+5K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+5K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+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—
+5K161151Spinal fixation systemCanwell Medical Co., Ltd.20161—
+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—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+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—