510(k) Report

Devices descending from K090047

205 later devices reach Synthes (Usa) 1.5MM Mini Fragment LCP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+1K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K193345Arthrex DynaNite Compression PlateArthrex, Inc.20200—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+1K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+1K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811—
+1K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K161303dynaMX™ Compression PlateMx Orthopedics, Corp.20171—
+1K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+1K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+1K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+1K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+1K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc.201113515
+1K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K253906Xpert HandNewclip Technics20260—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+2K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+2K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.20231—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+2K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+2K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+2K143721PRCT2Fx Solutions20150—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+2K140508Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc.201414—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+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—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+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—
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+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—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+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—