An investigational, bone regeneration device

Fusion of the ankle or hindfoot (including ankle joint fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, triple arthrodesis or double fusion) is often the best option for reducing or eliminating painful problems. In most fusion surgeries, bone has to be harvested from another area of your body, requiring a second surgery.

The investigational GEM OS^®1 device is actually a combination of a protein that is naturally found in your body and a synthetic (man-made) material, both of which have been previously approved by the FDA, that a surgeon can use instead of autologous bone (meaning bone from your own body) to create the fusion. By using GEM OS1 instead of autologous bone, the need for a second surgery to harvest bone is eliminated.

GEM OS1 is biocompatible, or specifically formulated to be used inside the body without causing harm. While GEM technology has a history of safe and effective use in dental applications, its use in orthopedic procedures in the ankle and hindfoot is investigational and being evaluated in a clinical research study called the Foot and Ankle Fusion Study.

If you or someone you know has been diagnosed with a hindfoot or ankle condition that may require fusion or If you have questions regarding the Foot and Ankle Fusion Study, or would like information regarding clinical trial site locations in your area, please contact us.