FDA Clears New Knee Arthroplasty System From Exactech

Gainesville, Fla.-based Exactech Inc., which makes bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, has received clearance from the U.S. Food and Drug Administration to market the Optetrak Logic constrained condylar (CC) prosthesis for revision knee arthroplasty cases.

“The FDA clearance of Optetrak Logic CC further expands the Exactech knee system offerings for surgeons who desire predictable and reproducible outcomes,” said CEO David Petty said. “Our new revision system will give knee surgeons additional options to treat their patients with revision total knee surgery including difficult challenges like significant bone loss.”

The Optetrak Logic CC prosthesis is indicated for use in patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; this device is also indicated for when previous devices have failed.

The system is already in use in several international markets, and according to the company, has achieved good results.

The Optetrak Logic CC system will have limited U.S. availability in 2015, ramping up to a full market launch in 2016.