Xtant Medical gets FDA clearance for expanded indications: 5 key points

Spinal Tech

Xtant Medical received FDA clearance for product line extensions for the Irix-A interbody spacer.

Here are five key points:


1. The clearance allows Xtant Medical to add three different size configurations to Irix-A, a standalone interbody device used in anterior lumbar interbody fusions.


2. In addition to the extension, Xtant Medical can also expand the indications of use to include use with allograft, such as Xtant Medical's OsteoSponge.


3. Xtant will now add three additional degrees of lordosis to Irix-A, providing surgeons with a wider variety of choices to correct a patient's loss of lordosis and improve sagittal balance.


4. Currently, Irix-A offers a titanium and PEEK composite implant, with the additional option of titanium plasma coating, all with eight or 12 degree of lordosis for alignment with the curvature of the spine.


5. Xtant Medical plans to release the additional implant options to customers later in the year.


More articles on devices and implants:
DePuy Synthes launches Trumatch Titanium 3D-Printed Implants: 5 things to know

Chinese firm invests $14M in orthopedic device developer: 3 notes
Implanet receives FDA clearance for JAZZ Passer: 4 takeaways


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