Professor Finn Christensen, M.D., Ph.D., and founder and CEO of FBC Device, said, “There is overwhelming evidence that poor spinal alignment is associated with back pain and disability. When we started the company, our goal was to commercialize a series of implants to help surgeons easily restore alignment when performing spinal fusions, so that more of their patients would achieve good or even great results. We have now accomplished three elements crucial to reaching our goal:
- Regulatory approval, now in the United States along with a second implant that has been CE marked since 2013.
- Patents granted around the world to protect these two implant designs as well as others to follow.
- Documented clinical evidence demonstrating that the technology enables surgeons to restore normal alignment and that patients receiving the technology have excellent results in patient-based outcome measures.”
The FDA clearance brings FBC Device one step closer to its goal. To fully commercialize its products, the company will immediately engage interested parties capable of bringing the technology to large markets across the world.
Each individual has different alignment requirements; it is not one size fits all. The FBC technology is a two-piece interbody fusion device that allows for in-situ adjustment from nine to 21 degrees, enabling surgeons to simply adjust alignment for each patient’s need and then lock the two pieces relative to each other.
Statur-L is a two-piece anterior interbody fusion implant composed of PEEK (polyether ether ketone), with tantalum spheres used as radiologic markers. The two pieces articulate to allow the surgeon to adjust lordosis in situ. This new technology reduces expensive inventory, saves time for the surgeon and enables variable lordosis. Also, the implant has a keel, to enhance the stability of the implant when placed in lordosis. The implant is CE approved for use with supplemental fixation.