FDA Clears Matrix Surgical’s Omnipore High-Density Polyethylene Customized Surgical Implants

Atlanta, Ga.-based Matrix Surgical USA, which makes sterile, biocompatible, craniomaxillofacial implants, has received 510(k) clearance from the U.S. Food and Drug Administraion for its Omnimore high-density polyethylene customized surgical implants for use in craniofacial reconstruction and augmentation.

Matrix reports it is is currently one of only two companies in the world to have a 510(k) clearance for both off-the-shelf and patient-specific high-density polyethylene craniofacial implants.

Omnipore customized surgical implants are patient-specific devices derived from CT (computed tomography) scan data and are indicated for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. They are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

“Customized surgical implants have the ability to greatly reduce operative time and produce a better fit of the device to the specific defect, generating savings to public and private payers and better outcomes for surgeons and their patients,” said Founder and CEO John O’Shaughnessy. “Following our successful 510(k) clearance for off-the-shelf Omnipore surgical implants in 2013, we now have the ability to meet the growing needs of our U.S. customers in this all-important segment of the market.”

The firm has been marketing its customized surgical implants in Europe and is currently seeking additional regulatory clearances in other countries around the world.