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Dallen Medical gets FDA approval for adjustable fracture fixation offering
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Dallen Medical recently announced it has received FDA approval for the Tensyn Plug, the company’s new fracture fixation offering.
Advertised by the company as the first adjustable bone fixation device, the Tensyn Plug is the next-generation model of Dallen’s Tensyn Band and is indicated for syndesmosis, acromioclavicular joint / coracoacromial ligament stabilization, mid-foot, lower foot, and wrist and hand fixation. The Tensyn plug incorporates a wide suture band to more evenly distribute fixation stresses and facilitate locking, something the plug offers without sutures, according to a company press release.
The device also allows for greater physiological natural movement of the affected joint, according to the release.
“We have evolved our Tensyn Band technology one step further, providing an implant with virtually unlimited application across small extremities for fixation with or without plating,” David Mills, CEO of Dallen Medical, said in the release. “In addition, the company will be making another submission to the FDA shortly for the expanded use of the Tensyn Plug in the knee and hip.”
Reference: www.dallenmedical.com