510(k) Report

Devices descending from K983873

30 later devices reach Syntec-Taichung Non-Sterile DHS/DCS Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072562Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd.200825—
+1K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc.200629—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811—
+2K111008Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd.20120—
+2K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd.201014—
+2K090786Kens Internal Fixation SystemKens Finemedtech Sdn. Bhd20091—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.20231—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+3K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K153573ConvergeBiomedical Enterprises, Inc.20160—
+3K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc.20152—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K161303dynaMX™ Compression PlateMx Orthopedics, Corp.20171—
+4K143721PRCT2Fx Solutions20150—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K193345Arthrex DynaNite Compression PlateArthrex, Inc.20200—