NGMedical has announced that its titanium cervical Bee cage has received clearance from the US Food and Drug Administration (FDA). According to the company the Bee cage is designed to challenge the limits of additive manufacturing.
NGMedical claim in a press release the Bee cage is purposefully designed with a honeycomb-like endplate, which reduces the risk of subsidence while allowing fusion. According to the company, the honeycomb structure allows for bony ingrowth and demonstrates the reduced use of titanium minimising risks of X-ray artefacts, while offering a very large graft space.
Nino Weiland, operations manager of NGMedical, Nonnweiler, Germany, commented, “This is an important step for NGMedical and allows us to start our active market presence in the USA. We are proud having 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.”
“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 US surgeon as it addresses every key metric including: anatomical design for bony fusion, maximum porosity with improved imaging and increased surface area minimising subsidence,” added Josh Sandberg NGMedical, Scottsdale, USA.