New Total Ankle Replacement Receives FDA Approval

The Food and Drug Administration has announced approval of the Scandinavian Total Ankle Replacement (STAR) system from Small Bone Innovations, Inc. This implantable total ankle replacement system is intended for use in patients where there is severe arthritis or other deformities that hinder the range of motion of the joint.
Small Bone Innovations claims that this design of the STAR system is the first of its kind because it relies on movable bearings that glide across the surface of polyethylene. The advantage is that this still affords some joint movement as opposed to traditional fusion surgeries that join the tibia to the talus bone for additional strength but severely limit motion.

“This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.”
Press release : FDA Approves New Total Ankle Replacement System
Company profile : Small Bone Innovations, Inc.
Flashback : Non-Metal Ankle Replacement Available at UCSD