Exactech wins FDA 510(k) for Vantage total ankle.

Exactech (NSDQ:EXAC) said today it won FDA 510(k) clearance for its Vantage total ankle designed to treat patients with arthritis in the ankle.

The Vantage total ankle is designed for total ankle arthroplasty, with a curved surface talar component and curved talus and anatomic tibia designs, the Gainesville, Fla.-based company said. The device incorporates a press-fit bone cage, the same unit used in the company’s Equinoxe shoulder system.

“With the introduction of the Vantage Ankle, Exactech continues its precedent of innovation in the extremities market, which began with our industry-leading Equinoxe platform shoulder system. The ankle market is in need of advances in total ankle technologies. We have had the pleasure of working with a world-class design team that includes surgeons who have dedicated their careers to treatment of the ankle. Together, we have developed an implant that we believe will be an improvement for patients who need a total ankle,” extremities marketing exec veep Darin Johnson said in a press release.

Exactech said it plans to initiate a targeted clinical evaluation of the total ankle this summer, with a planned full-scale release planned for the Q1 2017.

“I am impressed with Exactech’s ability to convert concepts from their other successful total joint replacement systems. The company’s engineers have successfully turned our ideas into an exciting new treatment option for end-stage ankle arthritis. On behalf of the design team and engineers, I look forward to sharing the Vantage ankle with other surgeons so their patients may benefit from this meaningful new technology,” American Orthopaedic Foot and Ankle Socity prez Dr. Mark Easley said in a prepared statement.

In January, Exactech said it sold the entirety of its dental biologics business to Salvin Dental Specialties, through its Salvin Regenerative subsidiary. Financial terms and other details of the deal were not disclosed.

Salvin Dental develops, manufactures and markets implant dentistry regenerative biomaterials and surgical instrumentation, Exactech said.

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