510(k) Report

Devices descending from K082300

50 later devices reach Anatomic Locking Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231623Distal Elbow Plating SystemSkeletal Dynamics, Inc.20230—
+1K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+1K171590Distal Elbow Plating SystemSkeletal Dynamics, LLC20171—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+1K140892Distal Elbow Plating SystemSkeletal Dynamics, LLC20142—
+1K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K103408Posterior Lateral PlatesDePuy Orthopaedics, Inc.20103—
+1K101421Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…DePuy Orthopaedics, Inc.201032—
+2K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+2K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+2K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+2K172008ARIX Humerus SystemJeil Medical Corporation20173—
+2K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing20151718
+2K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+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—
+3K251620A.L.P.S. Proximal Humerus Plating SystemZimmer Biomet20250—
+3K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+3K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+3K230938ARIX Humerus SystemJeil Medical Corporation20230—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.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—