KLS Martin Pure Pectus System

The KLS Martin Pure Pectus System is a surgical implant system consisting of metallic bars (pectus bars and connector bars) made from titanium alloys. It is designed to provide structural support to the thoracic cavity during repair of pectus excavatum, a chest wall deformity. The system is indicated for use in both adult and pediatric populations and is provided non-sterile with instruments for surgical placement.

The subject device extends the pectus bar sizing range to include longer bars greater than 380 mm and up to 500 mm, compared to the predicate's 200–380 mm range. Both angled and straight pectus bars are offered in these extended sizes. The bars are manufactured from CP Titanium and connector bars from Ti-6Al-4V using traditional manufacturing methods. An alternative manufacturing processing aide was introduced but manufacturing steps, raw materials, and cleaning methods otherwise remain identical to the predicate.

ASTM F382-24 for static and dynamic four-point bending tests; ASTM F2052-21 for magnetically induced displacement; ASTM F2213-17 for torque testing; ASTM F2119-07 (R2013) for image artifacts; ASTM F2182-19e2 for RF-induced heating; ISO 10993-23 for intracutaneous reactivity testing.

The subject and predicate devices have identical intended use (pectus excavatum repair in adult and pediatric populations), same principles of operation, and the same fundamental technology (metallic implants for thoracic support). The extended length pectus bars demonstrate substantially equivalent mechanical performance via four-point bending testing and identical manufacturing processes with only a minor processing aide change. Non-clinical MR environment testing confirms conditional safety. No new safety or effectiveness questions are raised by the size extension.