FDA Clears Blue Belt Knee

Pittsburgh, Pa.-based Blue Belt Technologies Inc. has received U.S. Food and Drug Administration 510(k) clearance to market its Stride unicondylar knee implant system. The company will co-market Stride alongside its NavioPFS precision orthopedic surgical system, which has been commercially available in the United States since December.

“We are excited to be able to offer the Stride implant on our NavioPFS surgical system,” said Eric B. Timko, president and CEO of Blue Belt Technologies. Our design team, led by Dr. Jess Lonner, focused on optimizing the Stride implant to integrate seamlessly with the NavioPFS system. We can’t thank Dr. Lonner enough for his leadership on this project. Additionally, we remain focused and committed to continuing to build out NavioPFS’ open architecture for implant selection. Allowing our customers to adopt technology while continuing to maintain their long-term existing relationships with implant manufacturers will allow Blue Belt to reach a wider physician audience.”

“Stride’s optimized aspect ratios, implant design and size offerings will reduce the need for compromise and enhance functional and clinical outcomes,” said Jess Lonner, M.D., attending orthopedic surgeon at the Rothman Institute, Philadelphia, Pa. “Additionally, its geometry interfaces well with NavioPFS to allow efficient and accurate bone preparation.”

Blue Belt Technologies makes smart surgical instruments for use in orthopedic procedures and other surgical specialties including neurosurgery, spinal and otolaryngology.