The US Food and Drug Administration (FDA) has granted 510(k) clearance to Providence Medical Technology for its PMT Bone Screws, designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation.
Providence Medical Technology chief executive officer Jeff Smith said the FDA clearance represents an important step in broadening the company’s posterior cervical platform of single use disposable instruments and implants.
"Posterior indirect decompression and fusion provides a compelling minimally-invasive alternative for patients suffering from cervical radiculopathy," Smith added.
"I am encouraged by our team’s ability to develop new products and gain necessary regulatory clearances to support our growing DTRAX platform.
"We have launched two new products in the U.S. in 2012, and anticipate two additional products in 2013."
In addition to PMT Bone Screws, the posterior cervical platform includes DTRAX Graft, DTRAX cervical system in the US, and the DTRAX facet system outside of the US.