510(k) Report

Devices descending from K060361

734 later devices reach Xia Spinal System, Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+3K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+3K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+3K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K103292Trio Trauma Spinal SystemStryker Corporation201185—
+3K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+3K101070Expedium Spine SystemMedos International SARL20102601
+3K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+3K101144Modification to:Radius Spinal SystemStryker Spine201090—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K240526POWEReam Xia/SerratoStryker Instruments20240—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412