510(k) Report

Devices descending from K061854

216 later devices reach Xia Titanium Spinal System and Xia Stainless Steel Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+1K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+1K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+1K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+2K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+2K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+2K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+3K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+3K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+3K103292Trio Trauma Spinal SystemStryker Corporation201185—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+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—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221