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US FDA clears Exactech’s Optetrak Logic Constrained Condylar Prosthesis

Exactech has secured approval from the US Food and Drug Administration (FDA) to market its Optetrak Logic Constrained Condylar (CC) Prosthesis system.

The system, which will have limited availability this year, assists surgeons in complex revision knee arthroplasty cases. Exactech plans to market the device fully in 2016.

The device can be used in patients undergoing surgery for total knee replacement because of osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

It can also be used in case of the failure of earlier devices. Surgeons can achieve optimized implant placement and bone coverage.

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."

Exactech develops and markets orthopaedic implant devices, associated surgical instruments and biologic materials and services to hospitals and physicians.

The company has a facility Gainesville, Florida, where it manufactures several of its orthopaedic devices.

The orthopaedic products of Exactech are utilized in the restoration of bones and joints that have deteriorated due to injury or diseases like arthritis.