Dallen Medical Gets FDA OK for Ankle System
Dallen Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Tensyn band for fixation of ankle syndesmosis. A syndesmotic ankle sprain, also called a high ankle sprain, is a sprain of the syndesmotic ligaments that connect the tibia and fibula on the lower leg.
This clearance follows the 510(k) clearances that Dallen has received the past 18 months for both a polymer coated and non-coated Compressyn band and the company’s Compressyn staple for foot, ankle and hand fixation and repair.
This clearance also positions the company for an additional submission incorporating its polymer coating and titanium versions of the Tensyn band product-line, which is expected to be submitted later this month, officials said.
"Together, these products will give foot and ankle orthopedic surgeons and podiatrists a variety of surgical solutions to best meet the clinical and economic demands of all busy healthcare practices," said Dallen Medical's President and CEO David H. Mills. “The clearance reflects Dallen’s continual development of its proprietary fixation with compression technologies and an expansion of its extremities products."
The Compressyn and Tensyn devices provide clinicians with fixation-with-compression solutions for use in sternal closure, small bone, and sports medicine procedures. Dallen’s design requirement for its products is based around the bone healing principles of Wolff’s Law, which states that bones respond to mechanical loads by changing size, shape, and structure.
The company is based in San Clemente, Calif.