510(k) Report

Devices descending from K002858

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+5K173508Everest Spinal SystemK2m20189—
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K132303Implanet Spine SystemImplanet, S.A.201315—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+5K113666Xia 3 Spinal SystemStryker Spine2012251—
+5K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+5K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+5K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+5K083393Xia 3 Spinal SystemStryker Spine20092921
+5K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+5K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+5K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+5K072605Malibu Spinal SystemSeaspine, Inc.200767—
+5K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+5K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K250637VCFix Spinal SystemAmber Implants20250—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+6K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+6K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—