NGMedical, a German medical device manufacturer focused on creating innovative technologies for spinal application, receives FDA clearance for its purely additively manufactured titanium cervical BEE cage.
The BEE cage is designed to challenge the limits of additive manufacturing. The honeycomb endplate design reduces the risk of subsidence while enabling fusion. It also allows for bony ingrowth and reduced, use of titanium minimizing risks of X-ray artefacts, while offering a very large graft space.
Nino Weiland, Operations Manager, NGMedical, said: “This is an important step for NGMedical and allows us to start our active market presence in the USA. We are proud of 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.”
According to Josh Sandberg, NGMedical, Inc.: “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.”