Expanding Orthopedics Incorporated (EOI) has received CE mark for the FLXfit 15, an enhancement to the existing FLXfit 3D expandable cage. The FLXfit 15 expands up to 4mm and enables controlled lordosis correction of up to 15 degrees. There are two linear length options; a 40mm and a 32mm version.
The higher range expansion is designed to enable surgeons to restore lordosis angle up to 15 degrees. The 32mm length option is intended to offer flexibility in treating patients with smaller anatomies.
EOI states in a press release that the device offers surgeons the ability to deliver the largest, in-class, expandable transforaminal lumbar interbody fusion cage with 4mm height expansion and 15 degrees of lordosis correction on the market, through a small unilateral tube.
The device is the subject of a pending US Food and Drug Administration 510(k) review.