510(k) Report

Devices descending from K092609

51 later devices reach Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific20153—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical20140—
+1K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K213572JuniOrtho Plating System™Orthofix Srl20220—
+2K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+2K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+3K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+4K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—