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
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K113666Xia 3 Spinal SystemStryker Spine2012251—
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—
+4K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+4K090320Conquest Spinal SystemLife Spine20092—
+4K083393Xia 3 Spinal SystemStryker Spine20092921
+4K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+4K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+4K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+4K072605Malibu Spinal SystemSeaspine, Inc.200767—
+4K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+4K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+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—
+5K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+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—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+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—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+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—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+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—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072