510(k) Report

Devices descending from K031438

24 later devices reach Acumed Small Bone Locking Rod System II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+1K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+1K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171—
+1K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc.20169—
+1K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+1K143276Acumed Small Bone IM Nail SystemAcumed, LLC201510—
+1K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc.201510—
+1K071944Acumed Small Bone Locking System IIAcumed, LLC200715—
+1K032548IP-XS Compression Nail SystemPlus Orthopedics20035—
+2K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+2K250559GMReis Fibula Nail SystemGm Dos Reis Industria E Comercio20250—
+2K234128Phantom Fibula Nail SystemParagon 28, Inc.202401
+2K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+2K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+2K173656Arthrex FibuLock NailArthrex, Inc.20183—
+2K161371Sonoma Fifth Metatarsal Repair SystemSonoma Orthopedic Products, Inc.20170—
+2K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160—
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K081356Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20082—
+3K250197Estremo Fibular NailCitieffe S.R.L.20250—
+3K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+3K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+3K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+4K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—