510(k) Report

Devices descending from K082624

20 later devices reach Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+1K250155Xpert KneeNewclip Technics20250—
+1K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+1K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+1K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+1K202489AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating SystemAdvanced Orthopaedic Solutions, Inc.20202—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+2K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+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—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—