A Medical Device Daily

Small Bone Innovations (SBI; Morrisville, Pennsylvania) said the FDA has approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint. The new prosthesis is a mobile-bearing device, which relies on bearings that move across a surface of polyethylene, a flexible plastic.

The Scandinavian Total Ankle Replacement (STAR) system, made by SBI, is an alternative to fusion surgery and may allow for greater rotation and movement in the joint. Fusion surgery involves cementing the shin bone (tibia) – the thicker of the two bones in the lower leg – to the talus bone in the ankle. The procedure stabilizes the ankle, but significantly decreases the ability to move the foot up and down. Once arthritis or injury destroys the cartilage that cushions the ankle bone, the joints can become painful enough to warrant total ankle replacement.

"This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle," said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health. "For the first time in the U.S., a patient may retain some ankle mobility with this non-constrained, mobile-bearing device."