ARIX Pectus Bar System

The ARIX Pectus Bar System is a surgical fixation device used to repair pectus excavatum and other anterior chest wall deformities. It consists of a pectus bar and stabilizer that lift the sternum upward to correct the concave chest deformity in minimally invasive procedures. The system can be configured as a single, double, or multi-bar system depending on the clinical need.

The device is a metallic bone fixation appliance with no significant differences in design features, material, surface treatment, sterilization methods, biocompatibility, or performance compared to the predicate devices. It functions as an internal fixation component with equivalent technological characteristics to Park's Pectus Bar System (K191057) and the ARIX Cannulated Screw System (K233912).

ASTM F382 (4-point bending test, 4-point bending fatigue test), vertical tensile test, 3-point bending test, and 3-point bending fatigue test. No clinical studies were performed.

The subject device has identical intended use (surgical repair of pectus excavatum) and equivalent technological characteristics (materials, design, sterilization) to the predicate devices. Bench testing demonstrates compliance with the same standards as the predicate, confirming equivalent mechanical performance. Since there are no significant design or material differences that would adversely affect the device's function or safety, substantial equivalence is established.