U.S. OKs Expanding Orthopedics’ 3-D Expandable Interbody Cage

Shortly after the good news from Europe, Expanding Orthopedics Inc. (EOI) has also earned a nod from U.S. regulatory authorities for its FLXfit, a 3-D expandable interbody cage. The U.S. Food and Drug Administration has cleared the device for sale in the United States.

“The FLXfit is the first TLIF [transforaminal lumbar interbody fusion] cage available worldwide with the 3-D expansion capability,” said CEO Ofer Bokobza. “This unique and patented technology combines minimal invasive access maximum footprint support and large bone graft chamber with unique lordotic expansion for sagittal balance correction.”

“I don’t know of any other cage commercially available in the US combining this many critical and beneficial features as the FLXfit,” said Hansen Yuan, M.D., a spine surgeon and director of EOI. “Minimal invasive through a single small port self-steering articulation for optimal placement large footprint for best stability and a large plate to plate bone graft chamber for solid bone fusion. The real revolution of the FLXfit is the combination of these features with the unique lordotic expansion technology which enables an optimal press fit while restoring the anatomy of the spine and lordotic angle correction. The FLXfit has the potential to change the way spine surgeons treat their patients today.”

Bokobza went on to say that EOI is in the process of signing distribution agreements with “leading U.S. spine distributors” and that he expects FLXfit to be on the market imminently.

Expanding Orthopedics makes expandable devices for spine surgery, and is based in Or Akiva, Israel.