NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its purely additively manufactured titanium cervical BEE cage.
The BEE cage is designed to challenge the limits of additive manufacturing. The purposefully designed 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 significant innovation from the team, who invented the first line of additively manufactured inter-body 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. Our team did a great job in cooperation with MRC Global,” 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,” according to Josh Sandberg of NGMedical, Inc.
“NGMedical is a hard-working, innovative team that worked diligently to ensure all necessary data was provided to support clearance through FDA for the BEE AM Cage,” says Christine Scifert of MRC Global.
NGMedical, Inc. is actively seeking qualified representation nationwide. If interested in learning more, please call us at (480) 609-4864.