510(k) Report

Devices descending from K082148

14 later devices reach Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC20171—
+1K143276Acumed Small Bone IM Nail SystemAcumed, LLC201510—
+2K250559GMReis Fibula Nail SystemGm Dos Reis Industria E Comercio20250—
+2K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+2K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171—
+2K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160—
+3K234128Phantom Fibula Nail SystemParagon 28, Inc.202401
+3K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+4K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+4K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+5K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—