NGMedical this week said it received FDA clearance for its additively manufactured titanium cervical interbody Bee cage.
The Bee cage is designed with a honeycomb-shaped endplate to reduce the risk of subsidence while allowing fusion in the spine. The structure allows for bony ingrowth with the reduced use of titanium to minimize the risks of X-ray artifacts with a large graft space.
“This is an important step for NGMedical and allows us to start our active market presence in the USA. We are proud to have received the FDA clearance based on the innovative design introduced to the OUS market in 2020. Our team did a great job in cooperation with MRC Global,” operations manager Nino Weiland said in a news release.
“The approval of the Bee cage is a remarkable accomplishment as it provides maximum surface area due to the honeycomb structure and laterally accessed lumen. This implant, along with its streamlined and elegant instrumentation, is perfectly suited for the U.S. surgeon as it addresses every key metric including anatomical design for bony fusion, maximum porosity with improved imaging and increased surface area minimizing subsidence,” Josh Sandberg of NGMedical said.