Xtant Medical Receives FDA Clearance for Expanded Indications of Irix-A

By Julie A. Vetalice

Xtant Medical received FDA 510(k) clearance to market line extensions for the Irix-A standalone interbody spacer, including three new sizes and use with allograft. The new implants will launch within 2017.

The Irix-A Lumbar Integrated Fusion system comprises a titanium ring surrounded by an outer PEEK composite ring and three screws, plus an optional titanium plasma coating to support osseointegration with the endplate. The new clearance adds additional degrees of lordosis, and the product can now be used with Xtant's OsteoSponge, 3Demin or OsteoVive viable cell allograft.

Irix-A received its initial 510(k) clearance in 1Q15, with CE Mark approval secured one year later.

Source: Xtant Medical

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory