Nvision Gets FDA Clearance for Osteotomy Wedge System
San Antonio, Tex.-based Nvision has been granted 510(k) marketing clearance by the FDA for its Trigon Osteotomy Wedge system, an implant that helps to promote bone fusion.
The device is composed of a radiolucent polymer that allows it to be used in X-rays, computed tomography (CT) scans and magnetic resonance imaging (MRI) for monitoring the healing process.
The wedge is made of a polyether ether ketone (PEEK) polymer developed by Invibio Biomaterial Solutions and it includes hydroxyapatite, a naturally occurring mineral that is the main inorganic component of bone. The implant encourages multidirectional bone healing and improved fixation.