Exactech Wins FDA Nod for Optetrak Logic Prosthesis
Exactech’s Optetrak Logic constrained condylar prosthesis for revision knee arthroplasty cases has snagged FDA 510(k) marketing clearance, the Gainesville, Fla., devicemaker said Thursday.
The prosthesis is indicated for patients undergoing total knee replacement surgery caused by osteoarthritis, osteonecrosis, rheumatoid arthritis and post-traumatic degenerative problems.
The system will have a limited U.S. launch this year. The devicemaker is seeking CE Mark certification for the prosthesis, a spokesman told Device Daily.
The company has also filed 510(k) regulatory applications for the Alteon revision monoblock stem system for the hip, the Ambassador cervical plate system and Acapella One cervical spacer system for the spine, and the Vantage total ankle system. It hopes to have FDA approval for these devices later in the year. — Jason Scott