510(k) Report

Devices descending from K984251

372 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+4K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+4K103292Trio Trauma Spinal SystemStryker Corporation201185—
+4K101144Modification to:Radius Spinal SystemStryker Spine201090—
+4K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K173508Everest Spinal SystemK2m20189—
+5K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+5K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+5K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—