Exactech Receives FDA 510k Clearance for Its Optetrak Logic Constrained Condylar Prosthesis

Exactech, Inc.

, a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today it 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. Exactech CEO David Petty said, "The FDA clearance of Optetrak Logic CC further expands the Exactech Knee system offerings for surgeons who desire predictable and reproducible outcomes. 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." A surgeon-focused, patient-driven innovation, Optetrak Logic CC offers a modern solution for reproducibility in the most complex and challenging knee arthroplasty cases. The new addition to Exactech's clinically recognized knee system introduces an advanced implant system and precision tools to consistently achieve optimized implant placement and bone coverage. 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. Surgeons around the world have documented excellent Optetrak® results.1 Offering advanced approaches to knee replacement, the Exactech Knee system combines a clinically-recognized system of proven implant system with personalized surgical workflows for reproducible outcomes, case after case. The Optetrak Logic CC system will have limited availability in 2015, ramping up to a full market launch in 2016. For more information about the Exactech Knee system, visit www.exac.com.