The FDA has awarded First Ray – a startup led by Surgical Frontiers – FDA clearance for its Stealth Staple system, an intraosseous small bone fixation device for the treatment of arthrodesis, osteotomies and bone fractures.
Upon implantation, the system completely resides within the bone, thus minimizing complications linked to hardware, according to the company.
The Stealth Staple marks a step up in the current standard of care because it reduces pain and soft tissue irritation since it is completely contained within the bone. Moreover, Analysis and biomechanical testing have demonstrated superior strength, bone compression and resistance to forming gaps compared to bone plate and screw systems, the company said. — Anisa Jibrell