Blue Belt Technologies Announces US FDA Clearance to Market its STRIDE Unicondylar Knee System
Blue Belt Technologies, Inc., an innovative medical technology company commercializing robotic-assisted solutions for orthopedic surgery, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its STRIDE™ Unicondylar Knee implant system. The STRIDE implant will be co-marketed with Blue Belt Technologies’ NavioPFS™ precision orthopedic surgical system which has been commercially available in the U.S. since December, 2012.
“We are excited to be able to offer the STRIDE implant on our NavioPFS surgical system. 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,” said Eric B. Timko, President and CEO of Blue Belt Technologies. “Additionally, we remain focused and committed to continuing to build out NavioPFS’s 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. Additionally, its geometry interfaces well with NavioPFS to allow efficient and accurate bone preparation,” said Dr. Jess Lonner, attending Orthopedic Surgeon at the Rothman Institute, Philadelphia, PA.
The STRIDE Unicondylar Knee system is available for treatment of both medial and lateral compartment osteoarthritis. Blue Belt Technologies expects to begin marketing the STRIDE system immediately.
Blue Belt Technologies, Inc. is developing the next generation of “smart” surgical instruments for use initially in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology (“ENT”). The Company’s NavioPFS™ System incorporates patented technology to provide precise robotic control to surgeons via an intelligent, handheld, computer assisted bone cutting tool. The NavioPFS System provides the surgeon with a layer of safety and enhanced accuracy while performing bone shaping tasks through minimally invasive incisions. The Company’s STRIDE™ Unicondylar Knee system provides advanced implant features optimized for use with NavioPFS.