March 29, 2016- Parsippany, NJ: Extremity Medical, LLC announces that it has received 510(k) clearance from the FDA to market the Align Ankle Fusion System™. This plating system is intended to facilitate arthrodesis of the ankle including tibiotalocalacaneal and tibiotalar joints. Matt Lyons, Chairman and CEO of Extremity Medical commented,“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.” Wesley Stotler, DO stated,”The novel 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. Michael Clare, MD commented,“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.” The initial release of the Align Ankle Fusion System is scheduled for mid-April 2016. Extremity Medical, LLC is an orthopedic device company specializing in the development of next generation systems addressing unmet needs for the extremity surgeon. The company currently has 14 products released globally which include specialized fixation and advanced arthroplasty systems for the lower and distal upper extremities. The company’s products are covered by an extensive portfolio of existing and pending patents.
