510(k) Report

Devices descending from K062270

460 later devices reach Radius Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+1K101144Modification to:Radius Spinal SystemStryker Spine201090—
+1K092631Mantis Redux Spinal SystemStryker Spine2009110—
+1K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+1K083393Xia 3 Spinal SystemStryker Spine20092921
+1K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+1K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+1K070631Device Modification to Radius Spinal SystemStryker Spine2007201—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+2K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+3K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+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—
+3K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—