New Cervical Plate from X-spine Systems Passes FDA Muster

X-spine Systems received U.S. Food and Drug Administration clearance for its Aranax cervical plate. The system will release to a limited list of surgeons in the fourth quarter of this year, with a full launch following in early 2016.

According to company officials, the Aranax system “represents the latest generation” of anterior cervical fixation with an enhanced locking mechanism, low-profile features, increased screw angulation and intuitive instrumentation. Indications for the Aranax implant include fusion on one to four contiguous levels of the cervical spine, through an anterior approach (C1-C7, inclusive).

The sterile packaging will reduce facility processing costs for hospitals and improve procedure planning, company officials added.
”The pre-packaged sterile implants and streamlined instrumentation are both beneficial and convenient,” said Aranax project team member and neurosurgeon Brandon Scott, M.D. “This translates to a direct cost savings for facilities while maintaining continuity of care for patients.”

According to a recent report from iData Research, approximately 220,000 cervical plating procedures were performed in 2014 in the United States, and the total addressable U.S. market for Aranax exceeds $160 million.

X-spine Systems is a unit of Belgrade, Mont.-based Xtant Medical Holdings Inc., which develops products for orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries.