KLS Martin Ixos System

The KLS Martin Ixos System is a metallic bone fixation device consisting of titanium alloy plates used with bone screws and locking pins for internal fixation, alignment, stabilization, and reconstruction of the radius and/or ulna. It is indicated for forearm fractures, osteotomies, and arthrodeses in adults and children aged 2 and older with fused or non-crossed growth plates.

The device is manufactured from Ti-6Al-4V using identical manufacturing, sterilization methods, and materials as the predicate device KLS Martin LINOS Wrist System. The primary difference is that the subject device includes anatomically pre-contoured plates designed to conform to the dorsal aspect of the radius, distal ulna, and shaft portions in left and right configurations, plus new intraoperative sizers for placement assistance.

Comparative static and dynamic mechanical performance testing was conducted in accordance with ASTM F382 Standard Specifications and Test Methods for Metallic Bone Plates. MR environment safety testing followed ASTM F2052-21 (displacement force), ASTM F2213-17 (torque), ASTM F2119-07 (image artifacts), and ASTM F2182-19e2 (RF-induced heating).

The device has the same intended use, fundamental technology, materials, and manufacturing methods as the primary predicate (K222624 LINOS Wrist System). Non-clinical testing demonstrates the subject device performs as well as or better than reference devices, establishing substantial equivalence despite the anatomical plate shape differences.