NGMedical GmbH Receives FDA OK for AM Titanium Cervical Interbody BEE

NGMedical, a German medical device manufacturer focused on creating technologies for spinal application, announces FDA clearance for its additively manufactured titanium cervical BEE cage.

The BEE cage is designed to challenge the limits of additive manufacturing, company says. The honeycomb endplate design reduces the risk of subsidence while allowing fusion. The honeycomb structure allows for bony ingrowth and demonstrates the reduced use of titanium minimizing risks of X-ray artefacts, while offering a very large graft space. This is another innovation from the team, who invented the first line of additively manufactured interbody devices.

"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," says Nino Weiland, operations manager of NGMedical.

"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," says Josh Sandberg of NGMedical.

Sources: Press materials received from the company and additional information gleaned from the company’s website.