510(k) Report

Devices descending from K012870

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080773Thor Anterior Plating SystemStryker Spine2008101—
+1K073437Thor Anterior Plating SystemStryker Spine200810231
+1K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+1K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+1K062698Trio + Spinal SystemStryker Spine2006882
+1K061854Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine2006216—
+1K061202Revere Stabilization SystemGlobus Medical, Inc.2006547—
+1K053115Xia Spinal SystemStryker Spine2005889—
+1K052971Stryker Spine Trio Spinal Fixation SystemStryker Spine20051122
+1K051973Modification to: Xia Stainless Steel SystemStryker Spine20050—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+2K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+2K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+2K142699LITe Plate SystemStryker Corporation201446—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+2K111479Revere CrosstopGlobus Medical, Inc.2011232—
+2K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+2K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+2K101144Modification to:Radius Spinal SystemStryker Spine201090—
+2K100788Cocr RodsGlobus Medical, Inc.2010374—
+2K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+2K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+2K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+2K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+2K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+2K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+2K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+2K080928Xia Spinal System, Stainless Steel Uni-Planar ScrewsStryker Spine2008182—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+2K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+2K063601Pilot Spinal SystemLife Spine200724—
+2K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+2K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+2K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20067341
+3K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K173508Everest Spinal SystemK2m20189—
+3K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691