510(k) Report

Devices descending from K160069

9 later devices reach Sonoma Fibula Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+1K173656Arthrex FibuLock NailArthrex, Inc.20183—
+1K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+2K250197Estremo Fibular NailCitieffe S.R.L.20250—
+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—