LOQTEQ® VA Proximal Humerus Plate 3.5

The LOQTEQ® VA Proximal Humerus Plate 3.5 is a titanium alloy bone fixation device indicated for treating fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone. It consists of plates with variable-angle (VA) locking screw holes and corresponding locking screws that provide multidirectional fixation.

The device features short and long plates (84–255 mm in length) with one oblong non-locking hole and multiple VA locking 3.5 mm screw holes. It incorporates multidirectional polyaxial or variable-angle locking screw hole technology identical to the reference device K230141. The plates and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3, matching the predicate devices.

ASTM F136, ISO 5832-3, ASTM F2182, ASTM F2052, ASTM F2213, ASTM F2119, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, and ASTM F543. Testing included moist heat sterilization validation to 10⁻⁶ SAL, magnetic resonance safety, and mechanical testing of plate and screw constructs.

The subject device uses identical materials, design principles, and manufacturing processes as the primary predicate K211582 and reference devices K121495, K230141, and K233008. All components are manufactured in the same facilities using identical materials and sterilization methods, with mechanical testing demonstrating equivalent strength. The device encompasses similar physical dimensions and incorporates technology previously cleared in predicate devices.