Exactech Granted FDA Clearance for Vitamin E Acetabular Polyethylene Liner

By Julie A. Vetalice

Exactech received FDA 510(k) clearance to market Novation XLE Vitamin E acetabular polyethylene liners for hip replacement, designed to work with the Novation® Crown Cup® Acetabular System featuring InteGrip® printed 3-D porous material.

The bearing material in XLE liners is designed to yield low wear and is imbued with vitamin E, a natural antioxidant. This is intended to counteract oxidation before and after the device is implanted.

Novation XLE complements the company's hip products including the Alteon® HA Femoral Stem, Tapered Wedge Femoral, Neck Preserving and Monobloc Revision stems.

Source: Exactech, Inc.

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory