Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).
1 1400sâ1800s (The Renaissance) â Copper, iron, steel, and wood were the most common materials used for prosthetics during this period.  1863 â During the American Civil War, the U.S. started to see advancements in the field of prosthetics.
Silastic arthropathy is a complication usually of silicone implants used in orthopedic surgery for joint reconstruction. This process of particle synovitis can also be caused by introduction of other foreign materials used in prosthetic hardware such as metal, polyethylene, polymethylmethacrylate cement, etc. Distribution: Silastic arthropathy can occur at any of the bones where there is a prosthetic implant in place. However, involvement at the hand and wrist is most common at the carpal bones, a location that is more susceptible to stress forces.