A.L.P.S. Small Fragment Plating System

The A.L.P.S. Small Fragment Plating System is a titanium alloy (Ti-6Al-4V) plate and screw system that combines locking screw technology with conventional plating techniques. It is intended for fixation of fractures, osteotomies, and non-unions of small bones (clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula), particularly in osteopenic bone. The system includes plates, screws, and washers available in sterile and non-sterile options.

The A.L.P.S. Small Fragment Plating System is similar in intended use, basic shape, material, and performance characteristics to the predicate devices. There is no change in the fundamental scientific technology between the subject device and predicate devices. The system varies by plate sizes and number of holes to accommodate different patient anatomy.

ASTM F2182 (RF Heating), ASTM F2052 (Displacement Force), ASTM F2119 (Magnetic Torque), and ASTM F2213 (Image Artifact) were used to evaluate MR compatibility for MR Conditional labeling.

The device has identical indications for use as the predicate devices and shares the same fundamental scientific technology and basic design (titanium alloy plate and screw system). Because there is no change in the underlying technology and the intended uses are identical, differences in sizing or component variations do not raise different questions of safety and effectiveness, making the device at least as safe and effective as the legally marketed predicates.