510(k) Report

Devices descending from K082625

35 later devices reach Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242988Genostis Osteosynthesis SystemGenostis AF20250—
+1K213108Humerus & Ulna SystemAuxein Medical Private Limited20221—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K181587ORTHOLOC SPS Shoulder Plating SystemTornier, Inc.20181—
+1K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+1K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K143721PRCT2Fx Solutions20150—
+1K112663Enhatch Orthopaedics Patient/Technique-Specific HumeralEnhatch Orthopaedics, LLC20120—
+1K110320Comprehensiveproximal Humeral Plating SystemBiomet Manufacturing Corp20110—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K191711ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc.20190—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+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—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—