Nvision Gets FDA Clearance for First Osteotomy Wedge Implant Made of Specialty PEEK Compound

Medical device and implant manufacturer Nvision Biomedical Technologies, San Antonio, Texas, has FDA clearance for what is said to be the first osteotomy wedge system made from PEEK-Optima HA Enhanced from Invibio Biomaterial Solutions (U.S. office in Conshohocken, Penn), a compounder of these bone on-growth biomaterials. Moreover, with a focus on driving innovation for the foot and ankle segment, Nvision has several new products in the pipeline utilizing PEEK-Optima HA material.

The Nvision Trigon Stand-Alone Osteotomy Wedge Fixation System reportedly has osteoconductive properties that promote multi-directional bone healing and improved fixation without introducing material-related bio-incompatibility reactions. Additionally, the Trigon system utilizes Structural Encoding (the patented technology platform licensed from Watershed Idea Foundry, Carlsbad, Calif.) to enable the Unique Device Identification (UDI) required by the FDA. The Trigon system is said to enable a standard surgical technique that allows direct and exact placement of implant and screws without additional plating. Nvision collaborated with Invibio for the FDA 510(k) submission to obtain clearance for the new implant.

PEEK-Optima HA Enhanced is said to provide a potential for earlier fusion/union for foot and ankle implants, a surgeon's primary goal for fusion surgery. It does so because hydroxyapatite (HA) is fully integrated within the matrix of Invibio's PEEK-OPTIMA Natural. As it is integrated, not coated, the HA is available on all surfaces of a finished device. In combination with a modulus of elasticity closely matching that of actual bone, PEEK-Optima HA Enhanced has the potential to promote faster bone on-growth and healing. Its radiolucent properties result in artifact-free imaging with the ability to easily monitor the healing process.