Arthrex Humeral Plating System and Cerclage Button

The Arthrex Humeral Plating System consists of straight titanium alloy plates (90.5–309 mm length) with suture holes for soft tissue refixation, used to repair proximal humerus fractures, dislocations, osteotomies, and non-unions, particularly in osteopenic bone. The Cerclage Button is a 3.5 mm threaded accessory designed for use only with this plating system and FiberTape cerclage suture to augment fracture stabilization.

The proposed plates are manufactured from titanium alloy (ASTM F136) rather than the predicate's material, and are offered in lengths outside the predicate size range. The Cerclage Button's indications have been updated to specify use only with the Arthrex Humeral Plating System and to reference the recommended Arthrex suture. Both devices are compatible with existing Arthrex 3.5 mm and 4.0 mm screws and are provided in sterile (gamma) and non-sterile single-use configurations.

ASTM F382-17 (4-point bend testing); ASTM F2052, F2119, F2182, and F2213 (MRI safety testing); ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, and EP 2.6.14 (bacterial endotoxins testing); and FDA guidance on MR environment safety.

The Arthrex plates and button share the same fundamental design, intended use, and scientific technology as the predicates (DePuy Synthes LCP Proximal Humerus Plate K180310 and Cerclage Positioning Pin K172975). Performance testing demonstrated statistical equivalence in 4-point bend strength. Material differences (titanium alloy) and extended plate lengths are considered minor variations that do not raise different questions of safety or effectiveness, as the devices perform the same bone fixation function with equivalent design configuration and sterility provisions.