Search Results

The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The purpose of this premarket notification is to expand the Ixos system to include anatomically pre-contoured plates designed to conform to the dorsal aspect of the radius, the distal ulna, and the shaft portions of both the radius and ulna. These plates will be available in both left and right configurations. In addition, new sizers will be introduced to the current Ixos system to assist with intraoperative selection and placement.

N/A

Ask a specific question about this device