An osteotomy wedge system made from Invibio Biomaterial Solutions’ PEEK-Optima HA Enhanced polymer has received 510(k) clearance from FDA. The Trigon Stand-Alone Osteotomy Wedge Fixation System was developed by San Antonio-based Nvision Biomedical Technologies.
The Trigon system has osteo-conductive properties that promote multi-directional bone healing and improved fixation without introducing material-related bioincompatibility reactions, said Nvision in the announcement. The device also uses Structural Encoding, which enables unique device identification, as required by FDA.
|The osteotomy wedge system made from Invibio Biomaterial Solutions’ PEEK-Optima HA Enhanced polymer has the potential to promote faster bone on-growth and healing. Image courtesy Nvision.|
"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. The device enables a standard surgical technique that allows direct and exact placement of implant and screws without additional plating. Nvision and Invibio collaborated in the 510(k) submission to FDA.
PEEK-Optima HA Enhanced has the potential to accelerate fusion/union for foot and ankle implants because hydroxyapatite (HA) is fully integrated within the matrix of Invibio's PEEK-Optima Natural line. Because it is integrated and not simply 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. The radiolucent material supports artifact-free imaging, allowing easy monitoring of the healing process.
After initially focusing on spinal implants, Nvision is now applying many of the same advanced technologies to lower extremity surgery. It launched the Vector Hammertoe Correction System, an industry first, in March 2019. The hammertoe system was the initial foot-and-ankle implant made from PEEK-OPTIMA HA Enhanced. It was also the first lower extremity implant to use Structural Encoding, the patented technology platform licensed from Watershed Idea Foundry, said Nvision in the press release. Earlier this year, Nvision also launched the Trigon titanium wedge, which uses a medical-grade titanium alloy (Ti-6AI-4V) in a 3D-printing process.
“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 achieve the best outcomes for their patients,” said Tom Zink, Senior Vice President of Product Development at Nvision.