Back in July, Dallen Medical submitted its 510(k) for the Tensyn™ band for fixation of ankle syndesmosis. Now the company is reporting that the FDA has duly cleared the product for market.
The clearance of Dallen Medical’s Tensyn band for Syndesmosis repair follows earlier clearances for both a polymer coated and non-coated Compressyn™ band for sternal closure, and its Compressyn staple for foot, ankle & hand fixation and repair.
Dallen’s modus operandum is the development of bone fixation devices that combine fixation with compression, so in the absence of any form of product detail or imagery on the entire internet we have to believe the Tensyn band adopts the same principle as its Compressyn systems. Repair of syndesmosis refers to the closure of the distal tibiofibular ligament that is often disrupted due to local trauma. Many companies offer syndesmosis repair solutions, from metal and absorbable screws through to slings and sutures. The Tensyn band device no doubt does the job, but we’ve yet to find another company that is so coy about sharing its technology with the outside world. A picture would be nice.
According to David Mills, President and CEO of Dallen Medical, “This clearance reflects Dallen’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.”
Source: Dallen Medical