Orthopedic company Dallen Medical has received 510(k) approval from the US Food and Drug Administration for its Tensyn Plug, an adjustable orthopedic fixation device.
Developed for orthopedic surgeons and podiatrists, the Tensyn Plug has received approval for syndesmosis, AC/CC joint stabilization, mid-foot (Lisfranc), lower foot, and wrist and hand repair.
Dallen Medical CEO David Mills said: "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.
"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."
The Tensyn Plug will allow surgeons to easily adjust the implant prior to locking into place in order to achieve optimal reduction of the fracture.
The device integrates the firm’s Tensyn knotless banding technology for stabilized fixation of soft tissue in the extremities and uses a wide suture band that distributes fixation forces more broadly than alternative products.
According to the company, the Tensyn Plug is the enhanced version to its predecessor Tensyn Band and provides lower profile and knotless fixation implant.