US FDA clears Xtant Xsert expandable lumbar spacer

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The US Food and Drug Administration has cleared Xtant Medical’s Xsert lumbar expandable interbody system.

The Xsert system is an all-titanium interbody device that can expand in-situ. It is available in various sizes and lordotic angulations, in order to fit the most complex anatomical needs of patients. The spacers are designed to simplify surgeon insertion techniques while offering implant height adjustability. Osseointegration will be encouraged through nano-textured endplate surfaces, according to a company release, as well as through central and lateral implant graft windows. The system is intended for use at one or two contiguous levels (L2-S1 inclusive).

Xsert is also cleared to be packed with autograft or allograft bone graft.

“We are very pleased to have received clearance for Xsert. This system allows the surgeon to implant the cage in a tighter corridor and then expand the device according to the patient’s anatomy,” states David Kirschman, developer of Xsert and current member of the Xtant Medical Board of Directors.

Xsert should be available in an initial product release in mid-2017.

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