Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

The Arthrex Humeral Plating System consists of contoured titanium humeral plates (92–265 mm long) with suture holes, used to repair proximal humerus fractures, osteotomies, and non-unions, particularly in osteopenic bone. The accompanying 4.5 mm cerclage button works with the plating system and FiberTape cerclage suture to augment fracture stabilization and cannot be used alone.

The Anatomic Humeral Plate is contoured and curved (versus straight in predicates), with 3–15 screw hole configurations in lengths within the predicate range. It accepts 4.5 mm cerclage buttons in the distal shaft and is compatible with 3.5 mm, 4.0 mm, and 4.5 mm Arthrex screws. The 4.5 mm cerclage button uses double Nylon/Nylon pouch packaging, identical to predicate lateral plate packaging.

ASTM F382-17 (4-point bend testing), ASTM F2052 (magnetically induced displacement force), ASTM F2119 (MR image artifacts), ASTM F2182 (RF-induced heating near implants), and ASTM F2213 (magnetically induced torque). Material conforms to ASTM F136 (titanium alloy).

The device has the same intended use, fundamental scientific technology, materials, and MRI safety labeling as the primary predicate K243995 and additional predicate K180310. Design differences (contoured shape, screw hole configurations, 4.5 mm button size) are minor and do not raise new safety or effectiveness concerns; performance testing demonstrates statistical equivalence to the primary predicate.