510(k) Report

Devices descending from K950697

849 later devices reach Depuy Motech Moss Miami Spinal System - Pedicle Fixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+1K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+1K120696Tiger Spine SystemCorelink, LLC201241—
+1K101144Modification to:Radius Spinal SystemStryker Spine201090—
+1K092605Xia 4.5 Spinal SystemStryker Spine200998—
+1K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+1K083393Xia 3 Spinal SystemStryker Spine20092921
+1K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+1K063601Pilot Spinal SystemLife Spine200724—
+1K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+1K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+1K050461Xia 4.5 Spinal SystemStryker Spine2005742—
+1K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998413—
+2K253545Vulcan Spinal SystemK2m, Inc.20260—
+2K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+2K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+2K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+2K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+2K182240PASS LP Spinal SystemMedicrea International SA20182—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+2K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+2K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+2K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K151362HC Spinal SystemHung Chun Bio-S Co., Ltd.20160—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+2K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+2K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133369Tiger Spine SystemCorelink, LLC201429—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131250Tiger Spine SystemCorelink, LLC201340—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K113666Xia 3 Spinal SystemStryker Spine2012251—
+2K111953Nautilus Spinal SystemLife Spine20123—
+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—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K111729Pilot Spinal SystemLife Spine, Inc.201113—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K103292Trio Trauma Spinal SystemStryker Corporation201185—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+2K082617Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd.20098—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K072685Ngarde SystemN Spine, Inc.200709
+2K071743Pillar Pedicle Screw SystemThe 4th Column, LLC20070—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K062698Trio + Spinal SystemStryker Spine2006882
+2K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005735—
+2K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+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—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—