Exactech Gains FDA Clearance for Alteon Cup and XLE Liner

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.

The Alteon platform includes a hydroxyapatite-coated femoral stem, designs for neck preserving and tapered wedge for primary procedures and the Alteon Monobloc Revision femoral stem.

Image courtesy of Exactech.

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