Versalock Upper Limb Plating System

The Versalock Upper Limb Plating System consists of titanium and titanium alloy plates and screws used for internal bone fixation in trauma and reconstructive surgery. It is intended for fixation of bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna. The devices are provided non-sterile and require cleaning and sterilization before use.

The subject device has the same basic design and intended use as the predicates, using identical materials (titanium/titanium alloy) and sterilization methods. Plates range from 1.4 to 3.5 mm in thickness and screws from 2.0 to 3.5 mm in diameter. The subject system differs from the cited predicate primarily in specific geometry and includes additional plate designs, though it is manufactured in the same facilities using identical manufacturing processes as previously cleared reference devices.

Mechanical testing of plates and screws was conducted according to ASTM F382 and ASTM F543, respectively.

The device is substantially equivalent because it shares the same basic design, indications for use, materials, and manufacturing processes as the predicate and reference devices. Although the subject device has specific geometric differences and additional plate designs, these are considered minor variations. All final components are manufactured in identical facilities using identical materials and processes as previously cleared devices, demonstrating material and biocompatibility equivalence. Performance testing confirms mechanical equivalence to the predicate devices.