Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a 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 the Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. These liners are designed to work in conjunction with the Novation® Crown Cup® Acetabular System including InteGrip® printed, 3-D porous material.

The advanced bearing material in the new XLE liners is designed for low wear and contains vitamin E. Oxidation in-vivo can contribute to polyethylene degradation in orthopaedic implant polyethylene. Vitamin E, a natural antioxidant, is blended into the raw material of Novation XLE liners to mitigate oxidative effects both before and after implantation.

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This product complements Exactech’s Hip product family, which also includes the Alteon® HA Femoral Stem, Tapered Wedge Femoral Stem, Neck Preserving Stem and Monobloc Revision Stem.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services 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 http://www.exac.com.