FDA Clears Ankle Fusion System From Extremity Medical

Extremity Medical LLC has received 510(k) clearance from the U.S. Food and Drug Administration to market the Align Ankle Fusion System. This plating system is intended to facilitate arthrodesis of the ankle including tibiotalocalacaneal and tibiotalar joints.

“Despite the growth seen over the last several years in the total ankle arthroplasty market, the rate of ankle arthrodesis has not slowed down at all. Extremity Medical believes that the Align Ankle Fusion System will offer significant advantages in both biomechanical and OR efficiencies as compared to the currently available ankle plating systems,” said Matt Lyons, chairman and CEO.

“The design of this plate with its anatomic contour, unique screw placement, reduction device, and fusion window provides an efficient and reproducible solution for primary to complex ankle fusion cases, including failed total ankle arthroplasty,” said Wesley Stotler, D.O.

The initial release of the Align Ankle Fusion System is scheduled for mid-April 2016.

“In my opinion, the most impressive features of the design of this ankle fusion system is its unique ability to provide the compression similar to that of several independently placed lag screws with the stability of an anterior plate, all through a single anterior approach,” added Michael Clare, M.D.

Extremity Medical LLC develops next-generation extremities systems. The Parsippany, N.J.-based company currently has 14 products released globally which include specialized fixation and advanced arthroplasty systems for the lower and distal upper extremities.