Belgrade, Mont.-based Xtant Medical earned FDA clearance to use autografts and/or allografts in its Irix-C cervical cage.
Here are five highlights:
1. The clearance also expanded the range of allowable levels from C3-T1 to C2-T1.
2. Before this clearance, the Irix-C cervical cage was only usable with autogenous bone graft.
3. Xtant's 3Denim and patented OsteoSponge, both allografts, will work with Irix-C.
4. OsteoVive, a cellular allograft, may also be used with Irix-C.
5. The Irix-C Cervical Integrated Fusion System is a standalone cervical intervertebral fusion device designed for degenerative disc disease treatment.