510(k) Report

Devices descending from K052390

53 later devices reach Synthes LCP Proximal Tibia Plates Line Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating SystemAdvanced Orthopaedic Solutions, Inc.20202—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K123964Axsos 3 TI Locking Plate SystemStryker Trauma AG201319—
+1K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+2K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K250155Xpert KneeNewclip Technics20250—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG201312—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K253906Xpert HandNewclip Technics20260—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+3K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—