U&I Corp. said Tuesday that it has received the U.S. Food and Drug Administration (FDA) approval for its facet screw fixation system.
The system uses a posterior spinal joint fixation screw that enables the stabilization of the spine by unifying the site of the pain through the fixation of the spinal joint. The screw treats degenerative diseases caused by unstable joints in the spine, and trauma, including spinal fractures or dislocations.
The company’s system can fix and stabilize the posterior joint with minimally invasive surgery. It is unique as it attaches spikes to the washer, which improves the fixation of the implant for ossification.
The unique double lock design on the head of the screw allows clinicians to maintain their predetermined angle making it easy to insert the screw. Medical workers will also be able to perform a more accurate and quick operation on their patients as the rotation radius of the screw is larger than that of the existing product.
“With the FDA approval, the company expects to accelerate its sales expansion into the U.S., which has the world's largest market for orthopedic surgery,” a company official said.
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