FDA Clears Nvision Biomedical’s Osteotomy Wedge System

Nvision Biomedical Technologies, a San Antonio, Texas-based medical device and implant manufacturer, has received U.S. Food and Drug Administration (FDA) clearance for the first osteotomy wedge system made from PEEK-OPTIMA HA Enhanced, a polymer from Invibio Biomaterial Solutions. The Nvision Trigon Stand-Alone Osteotomy Wedge Fixation System 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 to enable the Unique Device Identification (UDI) required by the FDA.
 
“The Trigon Osteotomy Wedge system, along with the entire foot and ankle line, is incorporating multiple technologies that I believe will be major factors in the future of reconstructive distal extremity surgery,” said Dr. Kyle Vaughn, founder of Paradise Valley Foot and Ankle in Phoenix, Ariz. The Trigon system, made from PEEK-OPTIMA HA Enhanced, enables 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 provides 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 ongrowth and healing. Its radiolucent properties result in artifact-free imaging with the ability to easily monitor the healing process.
 
After initially focusing on spinal implants, Nvision is now applying many of the same advanced technologies to lower extremity surgery, having launched the Vector®Hammertoe Correction System into the market in March 2019. An industry first, the hammertoe system was the initial foot and ankle implant made from the advanced, biocompatible PEEK-OPTIMA HA Enhanced. It was also the first lower extremity (Proximal Interphalangeal Joint Arthrodesis) implant to use Structural Encoding, the patented technology platform licensed from Watershed Idea Foundry. Last year, Nvision also launched the Trigon titanium wedge, which utilizes additive manufacturing and 3D-printed medical-grade titanium alloy (Ti-6AI-4V) material. 
 
“The ability to innovate with advanced materials, designs, and manufacturing processes allows us to add products to our portfolio that give surgeons the opportunity to achievethe best outcomes for their patients,” said Tom Zink, senior vice president of Product Development at Nvision. 
 
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.