VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System

The VOLT™ Ankle Trauma 2.7/3.5 Plating System and VOLT™ Calcaneus 2.7 Plating System are families of implantable metallic bone fixation plates made of stainless steel with variable angle screw holes. They are indicated for fractures, non-unions, and deformity corrections in the distal tibia, distal fibula, and calcaneus in adults and adolescents (12-21 years) where growth plates have fused.

The devices are iterations of prior DePuy Synthes plating systems with similar shapes, hole counts, screw sizes, and materials as predicate devices. Key differences include: (1) optimized dimensions allowing more targeted screw placement and improved construct stability, and (2) incorporation of the VOLT™ Locking Hole technology for 2.7/3.5mm locking capability.

Not stated in this summary.

The subject devices have similar intended use and indications as their predicates and are iterations of existing DePuy Synthes systems with comparable design, material, and fundamental technology. Non-clinical testing including finite element analysis, MR compatibility, and biocompatibility testing demonstrated that dimensional and locking hole differences do not raise new safety or effectiveness concerns, making the devices at least as safe and effective as predicates.