510(k) Report

Devices descending from K061621

172 later devices reach Synthes (Usa) 6.5 MM Cancellous Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+1K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+1K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd.20139—
+1K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+1K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC20120—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc.201113515
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221088Anatomic Bone PlateDouble Medical Technology, Inc.20231—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+2K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+2K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+2K140508Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc.201414—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151418Monster Screw SystemParagon 28201527—
+3K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc.20154—
+3K150121Zimmer Periarticular Plating SystemZimmer, Inc.201509
+3K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Zimmer, Inc.201412—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+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—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K153378Monster BITE Screw SystemParagon 28201522—
+4K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc.20150—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K141401Easy OutFeet For Life Podiatry Center20150—
+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—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—