510(k) Report

Devices descending from K023802

68 later devices reach Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.201811—
+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—
+1K132554Aap Loqteq Proximal Medial Tibia Plate 3.5Aap Implantate AG20131—
+1K113602Aap Loqteq Proximal Lateral Tibia Plate 4.5 SystemAap Implantate AG20120—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH2006254
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+2K230690Tandry Locking Plate SystemMicroware Precision Co., Ltd.20231—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+2K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+2K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH201911—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.201010—
+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—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+3K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135—
+3K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA201102
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—