510(k) Report

Devices descending from K071373

430 later devices reach Stryker Spine Xia Iii Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+1K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+1K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+1K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+1K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+1K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+1K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+1K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+1K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+1K132603Apex Spine SystemSpinecraft, LLC201325—
+1K121568Dali Spinal Fixation SystemAccel Spine20121—
+1K113666Xia 3 Spinal SystemStryker Spine2012251—
+1K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+1K092605Xia 4.5 Spinal SystemStryker Spine200998—
+1K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+1K083393Xia 3 Spinal SystemStryker Spine20092921
+2K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+2K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+2K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+2K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+2K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., 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—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—