KLS Martin Pure Pectus System

The KLS Martin Pure Pectus System is a metallic implant system used in surgical procedures to repair pectus excavatum and other anterior chest wall deformities in both adult and pediatric populations. It consists of straight and angled pectus bars made from titanium alloy, connector bars made from Ti-6Al-4V, and associated instruments for implant placement.

The subject device is manufactured from Ti-6Al-4V titanium alloy, whereas the primary predicate (MedXpert P.E.S.) uses 316L stainless steel. Both are permanent metallic implants with contact duration exceeding 30 days, intended to improve rotational stability of pectus bars. The subject device represents a line extension adding stabilizer bars to the previously cleared KLS Martin Pure Pectus System (K221938), with similar connector bar manufacturing and Type I/III anodization surface finishing.

ASTM F382-24 (static and dynamic four-point bending tests), ISO 10993-1:2018 (biocompatibility), ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-17 (torque), ASTM F2119-07 (image artifacts), and ASTM F2182-19e2 (RF-induced heating).

The device demonstrates substantial equivalence because it shares the same intended use and principles of operation as the predicate device (MedXpert P.E.S., K073556), has similar technological characteristics as a metallic pectus bar implant system, and non-clinical performance testing shows equivalent mechanical properties. Biocompatibility is established based on the titanium alloy composition already cleared in related devices. MR safety testing demonstrates the device is MR-Conditional and meets all acceptance criteria. No new safety or effectiveness questions were identified.