510(k) Report

Devices descending from K052761

735 later devices reach Modification to: Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+4K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+4K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130877Expedium Spine SystemMedos International SARL20138—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+4K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+4K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+4K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+4K101070Expedium Spine SystemMedos International SARL20102601
+4K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+4K101144Modification to:Radius Spinal SystemStryker Spine201090—
+4K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+4K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521