Orthofix International N.V., issued a news release in January announcing the company’s new anterior cervical interbody system which incorporates the benefits of PEEK with potential ingrowth from porous titanium endplates. We published the announcement shortly thereafter with a photo of the Construct Mini PEEK Titanium Spacer System being used in a multi-level case.
Ted Bird, the company’s senior vice president, global marketing has asked us to publish the following clarification:
“The image of the Orthofix International N.V. Construct Mini PEEK Titanium Spacer System provided on page 18 of the volume 9, Issue 2 Newsletter that shows the Construct Mini PEEK Titanium Spacer System without supplemental fixation in a multi-level case, which is an intended use that has not been authorized for marketing in the U.S. The FDA-cleared indications for use of the Construct Mini PEEK Titanium Spacer System are for spinal fusion procedures at one level in the cervical spine, (C2-T1) in skeletally mature patients with degenerative disc disease, (DDD). The Construct Mini PEEK Titanium Spacer System is intended for use with autograft and supplemental fixation system, (i.e. anterior cervical plate).”
We appreciate the clarification.
