SALT LAKE CITY, March 1 (UPI) -- Amedica said Wednesday its ceramic spinal implant -- an alternative to bone grafts -- has been OK'd for spine reconstruction.
The medical device firm said it has been cleared by the Food and Drug Administration to sell its Arx Ceramic Spinal Spacer System in what Amedica said is a U.S. market topping $600 million.
The company said its medical device is the first ceramic spinal implant cleared for use in humans and is designed to replace collapsed, damaged or unstable vertebral bodies cause by disease or injury.
"This clearance is a great leap forward for us," said Ashok Khandkar, president and chief executive officer of Amedica. "We are very excited to take the next step toward offering what we believe is the world's first FDA-cleared ceramic spinal implant system," he said.
The company said it has a more advanced ceramic spinal implant system in the works.
