KLS Martin Ixos System

The KLS Martin Ixos System is a bone fixation device consisting of metallic plates manufactured from Ti-6Al-4V titanium alloy, designed for internal fixation, alignment, stabilization, and reconstruction of distal radius and/or ulna fractures, osteotomies, and arthrodeses. The system is intended for adults and pediatric patients (ages 2-21) whose growth plates have fused or will not be crossed by fixation, and includes necessary surgical instruments for implant placement.

The subject device shares identical fundamental technology with its predicate—both use pre-contoured titanium plates with bone screws and locking pins for distal radius/ulna fixation. Key differences are limited to implant plate shapes: the subject device offers dorsal/dorsolateral straight or L-shaped plates and ulna T-shaped plates, whereas the predicate includes various palmar radius, ulnar, dorsal, and dorsolateral designs. The subject device adds MR Conditional labeling capability not present in the predicate.

ASTM F382 (Standard Specifications and Test Methods for Metallic Bone Plates) for comparative static and dynamic mechanical performance testing; ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213 for MR compatibility testing.

The device achieves substantial equivalence because it maintains identical intended use (distal radius/ulna fixation with identical patient population and clinical indications) and identical technological principles (titanium material, manufacturing methods, pre-contoured design) as the primary predicate KLS Martin LINOS Wrist System. Differences in plate geometry represent minor design variations within the same functional category. Non-clinical testing demonstrates equivalent or superior mechanical performance compared to the secondary predicate (Stryker VariAx 2), and MR Conditional labeling is an additional safety feature rather than a fundamental technological change, confirming the device poses no new risks.