Xtant Medical has secured approval from the US Food and Drug Administration (FDA) for its Xsert lumbar expandable interbody system.
Xsert system, which is an all titanium expandable interbody device that expands in-situ, is available in different sizes and lordotic angulations to be suited for complex anatomical needs of patients.
The new spacers will simplify surgeon insertion technique, while offering implant height adjustability.
Osteointegration will be promoted through nanotextured endplate surfaces, as well as central and lateral implant graft windows.
Xsert lumbar expandable interbody system can be used at one or two contiguous levels (L2-S1 inclusive).
The company has also secured approval for Xsert system to be packed with autograft or allograft bone graft.
According to the company, the 3Demin and patented OsteoSponge technology are better allografts to use with Xsert due, as they can compress, fill and expand in the device’s graft chamber, allowing for bone contact and fusion.
Xtant Medical board of directors member and Xsert developer Dr. David Kirschman said: "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.
"With the clearance of allograft use with Xsert, Xtant Medical further expands combined device and biologic solutions for surgeons and their patients."
Xtant Medical develops and markets regenerative medicine products and medical devices for domestic and international markets.