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 surgery to elevate the ribs and sternum. It is intended for pediatric and adult patients, with a recommended implantation duration of 2–3 years. The system comprises various sizes of straight and curved titanium bars, stabilizers, nuts, and claw fixators made of Ti-6Al-4V.

The subject device includes additional pectus bars and components with various dimensions (shorter and longer lengths and curvatures) compared to the predicate devices K243357 and K250892. However, engineering analysis demonstrated that the design modifications do not represent a worst-case condition. The device is identical to predicate devices in materials (Ti-6Al-4V), manufacturing process, design principles, and indications for use.

Mechanical bench testing was conducted in accordance with ASTM F382-17, including Static 4-Point Bending, Dynamic (fatigue) 4-Point Bending, and Vertical Tensile Tests. Engineering analysis was performed on the subject device to confirm worst-case justification relative to the predicate.

The subject device demonstrates substantial equivalence because it has identical indications for use, materials, manufacturing processes, and operational principles as the predicate devices. Engineering analysis confirmed that design modifications (additional bar sizes and curvatures) do not represent a worse-case condition, and mechanical testing of the predicate device established acceptable performance.