Astura Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Alta anterior cervical corpectomy spacer system.
Available in either HA PEEK or acid-etched Ti surface options, the system provides four different axial footprints in heights ranging from 15–50mm in 1mm increments. These features, coupled with a large central aperture for packing bone graft, maximise the contact between the implant and the vertebral body to help provide a greater opportunity for fusion, Astura said in a press statement.
In addition to the full commercial release of Alta Corpectomy, Astura will be launching its integrated plate/spacer platforms for lateral lumbar interbody fusion (LLIF), anterior lumbar interbody fusion (ALIF), and anterior cervical discectomy and fusion (ACDF) in the early part of next year.
“Our aim was to design a simple and efficient system that would allow our surgeon partners the intraoperative flexibility necessary to accommodate the wide array of anatomical challenges consistently encountered when performing a cervical corpectomy,” said Thomas Purcell, vice president of Astura Medical. “We believe the Alta cervical corpectomy system has delivered on that goal, along with further complementing our other best-in-class cervical solutions, Bridalveil OCT and Zion.”