FDA Clears EOI’s 3D Articulated Expandable Cage with 15-Degree Lordosis Correction

Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced FDA 510(k) clearance for the FLXfit15, enhancing the already successful FLXfit 3D Expandable Cage System. The FLXfit15 will expand the surgeon’s flexibility and capability by offering a family of products in different length options with infinitely adjustable expansion and lordosis correction of up to 4mm and 15⁰.
 
Dale Binke, EOI’s VP of US Sales, noted that, “One of the major trends in fusion surgeries is progression towards MIS style procedures, inpatient or outpatient.” However, Dale explains, “There is an inherent challenge in inserting a large interbody cage that restores lumbar lordosis while controlling sagittal and coronal alignment.” He added, “The FLXfit expandable cage is already providing the ultimate expandable TLIF solution, combining the best-in-class footprint that can be delivered through a MIS window and a unique expansion mechanism that restores lordosis.” Dale summarized, “With the FLXfit15, EOI’s engineering team has pushed the envelope a step further by combining an articulating cage with optimal footprint which can be easily delivered and expanded in a controlled manner up to 4mm and 15⁰ of lordotic restoration.”
 
Expandable cages are gaining market momentum and play a key role in successful fusion procedures. Ofer Bokobza, CEO of Expanding Orthopedics, comments, “The FLXfit System has already trail blazed the way for anatomical fit, expandable cages by providing great clinical promise so far.” Ofer said, “The FLXfit15 will further enhance the anatomical fit with its 15⁰ lordosis and the shorter footprint version (32mm) will offer great flexibility in treating patients with smaller anatomies.” He concluded, “We are thrilled with the release of the FLXfit15 in the US and certain that the enhanced versatility of the new FLXfit family will help gain a greater share in the fusion surgery market, both in MIS and open approaches.”