US-based Dallen Medical has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Tensyn band, designed for the fixation of ankle syndesmosis.
Previously, the company has obtained FDA 510(k) clearances for its polymer coated and non-coated Compressyn band, and its Compressyn staple for foot, ankle and hand fixation and repair.
Dallen Medical president and CEO David Mills noted this clearance reflects the company’s continual development of its proprietary fixation with compression technologies and an expansion of its extremities products.
"This clearance also positions the company for an additional submission incorporating our polymer coating and titanium versions of the Tensyn band product-line, which we expect to submit within a month.
"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," Mills added.
According to Dallen Medical, Compressyn and Tensyn technologies provide clinicians with next-generation fixation-with-compression solutions for use in sternal closure, small bone, and sports medicine procedures.