Matrix Surgical USA Receives 510(k) Clearance for OmniPore® DUROMAX® Surgical Implants for Orbital Reconstruction
Atlanta, October 18, 2018 – Matrix Surgical USA (www.matrixsurgicalusa.com), a leader in the development, manufacturing and commercialization of craniomaxillofacial implants, announced today that it has received a 510(k) clearance to market its OmniPore® DUROMAX® Surgical Implants, which are intended for non-weight-bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.
The DUROMAX orbital implant builds upon the previously cleared high-density polyethylene craniofacial implant platform by adding a commercially pure titanium construct embedded inside the porous polyethylene framework. The titanium has the advantage of shape retention after manipulating by hand and is radiopaque on post-operative computer tomography (CT) scans, unlike regular porous polyethylene implants without embedded titanium. The implants are for single use only and have a five-year shelf life.
According to John O’Shaughnessy, founder and CEO of Matrix Surgical USA, “The addition of DUROMAX to our ever-expanding line of craniofacial implants fills an important void in our portfolio.” O’Shaughnessy added, “We are very pleased with the response from the initial panel of surgeons who have evaluated DUROMAX and are eager to incorporate them into their clinical practice.”
Additional variants of DUROMAX are currently in development and are expected to be launched in early 2019 in markets where the company has regulatory clearances.
About Matrix Surgical USA
Matrix Surgical USA is a privately owned American company dedicated to the design, production, marketing and distribution of sterile, biocompatible craniofacial implants. Matrix Surgical USA offers its products to healthcare providers in the United States and in more than 45 countries around the world. Learn more at www.MatrixSurgicalUSA.com.