Nvision Biomedical Gains 1st 510(k) for a PEEK-OPTIMA HA Enhanced Osteotomy Wedge

By Julie A. Vetalice

Nvision Biomedical Gains 1st 510(k) for a PEEK-OPTIMA HA Enhanced Osteotomy Wedge

Nvision Biomedical Technologies received FDA 510(k) clearance for The Nvision Trigon® Stand-Alone Osteotomy Wedge Fixation System,  the first osteotomy wedge to be made from PEEK-OPTIMA HA Enhanced, a polymer from Invibio Biomaterial Solutions.

The initial version of Trigon, using additive manufacturing and 3D-printed medical-grade titanium alloy material, launched earlier in 2020. Trigon with PEEK-OPTIMA HA Enhanced has osteoconductive properties that promote multi-directional bone healing and improved fixation without introducing material-related bio-incompatibility reactions. Additionally, the system utilizes Structural Encoding® to enable the Unique Device Identification (UDI) required by FDA.

Nvision has several new products in its development pipeline based on PEEK-OPTIMA HA material.

Trigon supports a standard surgical technique that allows direct, 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.

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 2019.

“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.

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory