FDA clears FLXfit 3D expandable interbody cage

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Expanding Orthopedics has announced that its FLXfit, the world’s first 3D expandable interbody cage, is cleared for commercialisation in the USA.

Ofer Bokobza, chief executive officer of Expanding Orthopedics, says, “I am extremely proud of the Expanding Orthopedics team and our KOLs worldwide enabling us to reach this significant milestone. The FLXfit is the first TLIF cage available worldwide with the 3D expansion capability. 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.”

 


Hansen Yuan, a director at Expanding Orthopedics explains, “I do not know of any other cage commercially available in the USA combining this many critical and beneficial features as the FLXfit. 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.” Additionally, Yuan explains that 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.” He adds, “the FLXfit has the potential to change the way spine surgeons treat their patients today.”

 


Bokobza states, “Expanding Orthopedics is already in the process of signing distribution agreements with leading US spine distributors and I expect the FLXfit to quickly become a significant player in the  fast growing expandable cage’s segment based on its unique capabilities. This segment shows a steady 30% CAGR with an established reimbursement codes.”

 


Bokobza, concludes, “as part of our continuous strive to improve spine’s standard of care, the Expanding Orthopedics’s team together with its distinguished advisors is going to execute on our product pipeline and deliver a complete family of expandable cages based our expanding devices IP Platform. The expanding cages’ product family, coupled with the CE marked XPED expandable pedicle screw system, will reinforce our position as a leading company delivering innovative expanding devices and strengthen our vision as a driver for continuous improvement in spine care solutions.”

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