Osseus Fusion is an orthopedic development company that sponsored a team of BYU manufacturing and mechanical engineering students to develop a minimally invasive spinal fusion implant. Orthopedic surgeons currently have limited options that address the challenge of implementing minimally invasive techniques that do not damage the vertebrae further during insertion.
The Quad Wedge expandable spinal fusion implant designed by the team provides a so-lution. With a reduced profile, the implant is designed to be easily inserted between two vertebral bodies and then expanded to restore the optimal vertebral disc space height. This is achieved by using two counter-threaded screw bodies to drive four wedges along inclined grooves, which allows the im-plant to expand up to 157% of its original insertion height. Another advantage of the Quad Wedge design is the large graft window which allows for increased bone graft fusion compared to other marketed devices. Not only does it speed up the recovery process, but it offers surgeons a simple surgical pro-cedure with a single-tool insertion method
After multiple concept and design iterations, subsystem engineering, and prototyping the team created several validation and testing procedures. Based on detailed hand calculations, finite element analysis, and functionality testing, the Quad Wedge design is prepared to satisfy the rigorous demands of FDA requirements. Osseus Fusion will now proceed with the FDA approval procedure and develop an insertion instrument capable of rotating the two screws simultaneously. They hope to launch the product within a year.
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