Arthrex Humeral Nails

The Arthrex Humeral Nail System is a titanium intramedullary nail designed to treat stable and unstable proximal humerus fractures (two, three, and some four-part fractures), as well as proximal and distal one-third fractures, midshaft fractures, and pathological fractures. The device enters through the greater tuberosity and includes proximal and distal locking screws, a compression screw, and an end cap.

The proposed device offers distal diameters of 7.0 and 9.0 mm (compared to the original 8.0 mm predicate), while maintaining an unchanged proximal diameter of 10.0 mm. Nail lengths range from 15–30 cm, identical to the predicate. The device is newly evaluated and labeled as MR Conditional, whereas the original predicate was not evaluated for MR safety. Overall design, configuration, surgical technique, materials, and manufacturing processes remain identical to the predicate.

ASTM F1264-16 (static and dynamic four-point bend testing, fatigue testing, and static torsional testing); FDA Guidance on Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment (testing for magnetically induced displacement force, torque, RF heating, and image artifact).

The Arthrex Humeral Nail is substantially equivalent because it maintains the same fundamental design, materials, manufacturing, and surgical technique as the predicate AOS Humeral Nail (K050241). Performance testing demonstrates mechanical equivalence to a reference predicate. The modifications in distal diameter sizing and addition of MR safety evaluation are considered minor and do not raise safety or effectiveness concerns.