CastleLoc Pectus Bar System

The CastleLoc Pectus Bar System is a thoracic support device used to repair the chest wall and correct pectus excavatum (a sunken chest deformity) using minimally invasive surgical techniques. It is intended for use in pediatric and adult populations and includes various sizes of straight and curved bars made of Ti-6Al-4V titanium alloy, along with stabilizers, nuts, and fixators for securing the bar.

The CastleLoc Pectus Bar System comprises titanium bars and associated fixation components (stabilizers, nuts, claws) made of Ti-6Al-4V (ASTM F136). The system includes multiple bar sizes and designs (straight and curved) selected based on patient body size, similar in design and materials to the predicate devices.

ASTM F382-17 standards were used to verify mechanical performance through static and dynamic 4-point bending tests and vertical tensile testing. These non-clinical performance tests demonstrated that the CastleLoc system met specified acceptance criteria.

The device is substantially equivalent because it has undergone mechanical performance testing showing results similar to or higher than the primary predicate (Park's Pectus System K191057), demonstrating equivalent mechanical performance. The design features, indications for use, materials, and operational principles are substantially equivalent to the predicate devices, and side-by-side testing confirmed the CastleLoc system is at least as safe and effective as the predicate devices.