NGMedical yesterday said it received FDA clearance for its anatomically shaped cervical interbody Bee HA.
Bee HA is designed to optimize fusion while maintaining elasticity that is similar to bone and radiolucency of the cage body, according to the company.
It is made of PEEK-Optima Hydroxyapatite, which is a well-known osteoconductive material that enhances bone apposition. The HA is fully integrated, not coated, into the PEEK-Optima matrix.
“This is the next step for NGMedical to broaden our active market presence in the USA. We are proud to have received the FDA clearance for our new Bee HA. Our team did a great job in cooperation with MRC Global,” CEO Dagmar Weiland said in a news release.
“The clearance of the Bee HA cage is an important step to complete our portfolio with this innovative solution. This implant, along with its streamlined and elegant instrumentation, is perfectly suited for the U.S. surgeon as it addresses artifact-reduced imaging while enhancing fusion,” Josh Sandberg of NGMedical said.