Blue Belt, next generation surgical orthopedic instruments developer, has received 510(k) approval from the US Food and Drug Administration (FDA) to market its Stride Unicondylar Knee implant system.
With the clearance, the Stride implant will be co-marketed with Blue Belt Technologies’ NavioPFS precision orthopedic surgical system, which has been available commercially in the US since December 2012.
Blue Belt president and CEO Eric Timko said, "Additionally, we remain focused and committed to continuing to build out NavioPFS’s open architecture for implant selection."
Rothman Institute Pennsylvania attending orthopedic surgeon Jess Lonner said that the 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," Lonner added.
The Stride Unicondylar Knee system is used to treat medial as well as lateral compartment osteoarthritis. The company plans to market its new product immediately.