The US Food and Drug Administration (FDA) has cleared Xtant Medical’s product line extensions for the Calix-C family of cervical interbody cages. The clearance provides for the addition of two larger footprints, for use with allograft.
The Calix-C is now indicated for use with allograft comprised of cancellous and/or corticocancellous, bone graft, in addition to the current use with autograft.
The additional, larger footprints of Calix-C are designed for increased stability against the vertebral endplates, and allow for a larger lumen for bone graft, making it a better surgical option for a greater number of patients. The addition of the allograft indication and the larger sizes will all be available in polyetheretherketone (PEEK) and Titanium plasma-coated PEEK.
“This new FDA clearance allows Xtant Medical to leverage… our established allograft product offerings for use with our now expanded line of interbody devices in cervical discectomy and fusion procedures” states Gregory Juda, chief scientific officer and general manager of Xtant Medical. “We expect that the use of these products as a combined spinal fusion solution will result in positive patient outcomes.”
The Calix‐C cervical interbody spacer is intended for spinal fusion procedures at one level (C2–T1 inclusive) in skeletally mature patients, and is intended to be used with supplemental spinal fixation systems.
Xtant Medical is preparing for the alpha launch of the new Calix-C sizes later this year.