Expanding Orthopedics Inc., has announced that its FLXfit™, the world’s first 3D expandable interbody cage, has gained U.S. FDA 510(k) clearance for commercialization in the US.
Background
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.
Company comments
Spine surgeon Dr. Hansen Yuan, a Director at the company explained that “I don’t know of any other cage commercially available in the US 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, Dr. Yuan explained 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 added that “the FLXfit has the potential to change the way spine surgeons treat their patients today.”
Ofer Bokobza, CEO of Expanding Orthopedics, stated “EOI 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.”
Mr. Bokobza, concluded “as part of our continuous strive to improve spine’s standard of care, the EOI’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.”
Source: Expanding Orthopedics, Inc., PR Newswire
published: July 22, 2014 in: Approval/Clearance, Spine