510(k) Report

Devices descending from K143276

10 later devices reach Acumed Small Bone IM Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250559GMReis Fibula Nail SystemGm Dos Reis Industria E Comercio20250—
+1K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+1K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+1K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171—
+1K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160—
+2K234128Phantom Fibula Nail SystemParagon 28, Inc.202401
+2K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+3K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+3K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+4K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—