The US Food and Drug Administration (FDA) has granted 510(k) clearance to Dallen Medical's Compressyn Staple, designed for use in rigid small bone fixation, specifically in foot, ankle, and hand applications.
Using the company’s patented Compressyn technology, Compressyn Staple delivers superior fixation with dynamic compression in small bone applications, according to the company.
Dallen Medical CEO David Mills said the new Compressyn Staple offers physicians the ease of a staple with a new standard of rigid compression for small bone fixation.
"We are very pleased to receive this clearance and are excited about the potential for our Compressyn Staple to help improve patient outcomes and reduce costs for the healthcare system," Mills added.
The company’s Compressyn Band, which has been already cleared by the FDA for use in sternal closure, can also be used in sports medicine applications.