510(k) Report

Devices descending from K040777

26 later devices reach LCP Radial Head Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K141680AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN…Auxein Medical20151—
+1K110201Explor Radial Head Plating SystemBiomet, Inc.20110—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+2K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+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—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+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—