510(k) Report

Devices descending from K060710

187 later devices reach Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+1K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+1K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+1K151407RECON systemNormed Medizin-Technik GmbH20154—
+1K140508Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc.201414—
+1K120651Stabiliz Fixation SystemStabiliz Orthopaedics, LLC20121—
+1K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc.201113515
+1K082527Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc.20081605
+1K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH2008212
+1K063303Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc.20061464
+2K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+2K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+2K192021NCB Polyaxial Locking Plate SystemZimmer GmbH20191—
+2K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+2K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc.20154—
+2K150121Zimmer Periarticular Plating SystemZimmer, Inc.201509
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Zimmer, Inc.201412—
+2K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+2K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K113652Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq…Aap Implantate AG20128—
+2K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.201010—
+2K083654Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V…Zimmer, Inc.2009122
+3K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+3K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K202803Activmotion S DTONewclip Technics20210—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K173641Activ AnkleNewclip Technics20183—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160—
+3K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG20160—
+3K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+3K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+3K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc.20150—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K143721PRCT2Fx Solutions20150—
+3K151418Monster Screw SystemParagon 28201527—
+3K141401Easy OutFeet For Life Podiatry Center20150—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG20140—
+3K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+3K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135—
+3K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA201102
+4K261511Xpert AnkleNewclip Technics20260—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K213214Xpert WristNewclip Technics20210—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—