510(k) Report

Devices descending from K071184

62 later devices reach Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252959WRISTAR MultiAx Distal Radius KitIntrauma S.P.A20250—
+1K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+1K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+1K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+1K1101252.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA20115—
+1K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa)2010503
+1K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+2K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes…Gpc Medical Limited20220—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K170705ARIX Wrist SystemJeil Medical Corporation20172—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongDePuy Synthes20175—
+2K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+2K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+2K130774Universal Distal Radius SystemNewclip Technics20135—
+2K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K213214Xpert WristNewclip Technics20210—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+4K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+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—