FDA Clears Dallen Medical Small Bone Fixation Staple

San Clemente, Calif.-based Dallen Medical has earned 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its individually packaged, sterile Compressyn staple implant. The implants were already cleared last year for reusable applications in small bone fixation, specifically in foot, ankle and hand.

“This clearance allows Dallen to offer physicians the highest level of rigidity and compression with our proprietary Compressyn staple, but also at a price point to meet every hospital and surgery center’s budget,” said Dallen Medical President and CEO David H. Mills. “In the last 12 months, Dallen has received three FDA clearances and initiated commercialization of its first product, the Compressyn band for sternal closure. These milestones have positioned the company for what we expect will be an exciting 2014.”

Dallen’s portfolio of Compressyn devices offer fixation for sternal closure, small bone, and sports medicine applications.

Dallen Medical makes bone fixation and repair technologies and devices.