CastleLoc Pectus Bar System

The CastleLoc Pectus Bar System is a thoracic support device that corrects pectus excavatum and other anterior chest wall deformities using minimally invasive surgical techniques. It includes various sizes of straight and curved bars, stabilizers, nuts, and fixators, with recommended implantation time of 2–3 years, and is intended for pediatric and adult populations.

The subject device includes additional pectus bars with various dimensions (shorter and longer lengths) compared to the primary predicate. The device plates are offered in similar dimensions to an additional predicate. All components use the same materials, manufacturing process, design, and operational principles as the predicates.

Mechanical bench testing was conducted per ASTM F382-17, including Static 4-Point Bending, Dynamic (4-point bending), and Vertical Tensile Tests. Test results were compared side-by-side to Park's Pectus System (K191057).

The subject device demonstrates substantially equivalent mechanical performance to both predicate devices (CastleLoc K243357 and Park's K191057) based on ASTM F382-17 testing showing equal or superior test values. Since the device has identical materials, manufacturing, design, indications for use, and intended use as the predicates, with only dimensional variations in bar lengths and plate sizes that do not affect safety or effectiveness, it is substantially equivalent.