510(k) Report

Devices descending from K983583

965 later devices reach Depuy Acromed Moss and Moss Miami Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+3K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+3K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+3K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+3K072685Ngarde SystemN Spine, Inc.200709
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+3K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+3K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+3K051089Gii Spinal Fixation SystemCo-Ligne AG20054—
+3K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+3K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+3K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+3K033965Shiraz-Anterior SystemSpine Next America20040—
+3K033947Shiraz Posterior SystemSpine Next America20040—
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K033772Shiraz-Java Spinal Fixation SystemSpine Next America20040—
+3K031265Shiraz-Java Spinal Fixation SystemSpine Next SA20030—
+3K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc.2003250—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243249TriALTIS™ Spine SystemMedos International SARL20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+4K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—