510(k) Report

Devices descending from K032559

44 later devices reach Synthes 4.0MM Titanium (TI.) Locking Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+1K072250Supercable Grip and Plate SystemKinamed, Inc.200711
+1K041965Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc.200435—
+2K261038Xpert PFPNewclip Technics20260—
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+2K073432Trauson Bone PlateTrauson (Jiangsu) Medical Instrument Co., Ltd.20081—
+2K051412Humeral Head Plate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200521
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K173746Activmotion RangeNewclip Technics20181—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+3K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—