TRILEAP Plating System

The TRILEAP Plating System is a metallic bone fixation device consisting of titanium alloy plates (2.0–4.0 mm) and screws used for reduction, temporary fixation, fusion, and stabilization of foot and ankle bones. It is indicated for fixation of bones and bone fragments in adults and adolescents aged 12–21 years where growth plates have fused.

The subject devices are identical to the predicate devices (K230591) in fundamental technology, materials, and reprocessing methods but differ in some aspects of design. Non-clinical testing showed the subject plates were non-inferior in bending strength and stiffness, and subject Jones screws were non-inferior in torsional yield strength compared to predicate screws.

Testing was performed in accordance with FDA Guidance on Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway. Tests included plate 4-point bend, screw torsional strength, screw driving torque, screw axial pull-out strength (Chapman equation), and MR compatibility evaluation.

The subject devices have identical intended use and indications for use as the predicate device. Non-clinical performance data demonstrate that design differences do not raise new questions of safety and effectiveness, and the proposed devices are at least as safe and effective as the predicate devices.