510(k) Report

Devices descending from K061753

44 later devices reach Synthes (Usa) Clavicle Hook Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260761APTUS Clavicle System 2.8Medartis AG20260—
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K201959DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate SystemDePuy Synthes20202—
+1K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+1K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K141823Aap Loqtec Clavicle Plates 2.7/3.5Aap Implantate AG20140—
+1K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+2K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle…DePuy Synthes20201—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K173746Activmotion RangeNewclip Technics20181—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241539Activmotion SNewclip Technics20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—