May 21, 2016
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First Ray receives FDA clearance for Stealth Staple

First Ray recently announced it has received FDA 510(k) clearance for its Stealth Staple System. The Stealth Staple System is an intraosseous small bone fixation system for the treatment of arthrodesis, osteotomies and bone fractures.

According to a company press release, clinical complications from prominent hardware may be substantially reduced as the Stealth Staple is fully contained within the bone at implantation. In addition, the Stealth Staple reportedly creates evenly distributed compression across the opposing bone surfaces in fracture or osteotomy cases.

Finite element analysis and biomechanical testing have demonstrated superior strength, bone compression and resistance to gap formation with use of the system compared with the use of bone plate and screw systems, according to the release.  

 

Reference:

www.surgicalfrontiers.com