510(k) Report

Devices descending from K031090

891 later devices reach Modification to Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+7K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+7K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+7K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+7K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+7K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+7K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+7K132303Implanet Spine SystemImplanet, S.A.201315—
+7K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+7K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+7K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+7K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+7K120838Synthes Matrix SystemSynthes Spine201216—
+7K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+7K120571Synthes Uss ConnectorSynthes Spine201274—
+8K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—