Receives 510(k) Clearance for Alteon® Cup and XLE® Liner
Gainesville, Fla. (March 14, 2019)—Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a new acetabular system, Alteon® Cup and XLE® Liner for hip replacement surgery.
Seamlessly integrated with the Alteon Platform System, the Cup will provide multiple implant configurations and bearing options, which can be used for various surgical applications. Its asymmetric porous coating—TAC™ porous technology—strikes the optimal balance between material strength, pore size and porosity.
…The new Alteon Acetabular Component joins modern technology with beautiful design…
“The new Alteon Acetabular Component joins modern technology with beautiful design. An optimized fixation surface and head-liner-shell combinations make this socket, and the intent of its design, more versatile and reproducible, and therefore simply more fun to use,” said Jose Rodriguez, M.D., orthopaedic surgeon from Hospital for Special Surgery.
Exactech engineers worked with a renowned team of orthopaedic surgeons for the development of this project. The design team for the Alteon Cup included Derek Amanatullah, M.D., Ph.D., of Stanford Medical Center in Redwood City, Calif.; Roy Davidovitch, M.D., of the Hospital for Joint Diseases in New York City, NY; William Hefley, M.D., of Bowen-Hefley Orthopedics in Little Rock, Ark.; Jose Rodriguez, M.D., with Hospital for Special Surgery, New York City, NY; and Timothy van de Leur, M.D., of the Orthopaedic Institute, Ocala, Fla.
The Alteon Cup is used with the Alteon XLE highly crosslinked vitamin-E enhanced acetabular liners. A patented gamma irradiation and mechanical annealing process, tailored to the vitamin E content, is used to achieve the desired crosslink density for these liners.
“The clearance of this Cup is an important milestone for the Alteon Platform System,” said Senior Vice President, Exactech Reconstruction Business Unit, Steve Szabo. “This rounds out an already robust system, taking the Alteon portfolio to the next level.”
During the second half of the year, Exactech will aggressively expand its rollout of the Alteon Cup to serve more surgeons throughout the U.S. Full launch is expected later this year.
Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments, biologic materials and computer-assisted surgery technologies to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at https://www.exac.com.
Priscilla Bennett, APR
VP of Corporate Communications