Exactech Gains FDA Clearance for Alteon Cup and XLE Liner

By Julie A. Vetalice

Exactech received FDA 510(k) clearance to market the Alteon® Acetabular Cup and XLE® Liner for hip reconstruction.

The cup provides multiple implant configurations and bearing options for the Alteon portfolio and features TAC™ asymmetric porous coating.

Alteon XLE highly crosslinked vitamin-E enhanced acetabular liners undergo a patented gamma irradiation and mechanical annealing process, to achieve the desired crosslink density.

In 2H19, Exactech will expand U.S. rollout of the Alteon Cup; full launch is slated for late 2019.

Source: Exactech
Exactech Alteon Cup - ORTHOFLASH


Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory