510(k) Report

Devices descending from K913949

27 later devices reach True/Flex Humerus, Ulna & Radius Intramed Rods Sys through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.20070—
+1K031438Acumed Small Bone Locking Rod System IIAcumed, LLC2003241
+1K964243Humerus WiresCompagnie Financiere & Medicale (Cf&M)19960—
+2K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+2K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+2K163014AOS Small Bone Nailing SystemAdvanced Orthopaedic Solutions, Inc. (Aos)20171—
+2K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc.20169—
+2K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+2K143276Acumed Small Bone IM Nail SystemAcumed, LLC201510—
+2K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc.201510—
+2K071944Acumed Small Bone Locking System IIAcumed, LLC200715—
+2K032548IP-XS Compression Nail SystemPlus Orthopedics20035—
+3K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+3K250559GMReis Fibula Nail SystemGm Dos Reis Industria E Comercio20250—
+3K234128Phantom Fibula Nail SystemParagon 28, Inc.202401
+3K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+3K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+3K173656Arthrex FibuLock NailArthrex, Inc.20183—
+3K161371Sonoma Fifth Metatarsal Repair SystemSonoma Orthopedic Products, Inc.20170—
+3K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC20160—
+3K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+3K081356Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20082—
+4K250197Estremo Fibular NailCitieffe S.R.L.20250—
+4K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+4K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+4K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+5K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—