Matrix Surgical USA, a manufacturer of biocompatible craniofacial implants, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its high-density polyethylene customized surgical implants for use in craniofacial reconstruction and augmentation.
The company claims that it 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.
Matrix Surgical USA founder and CEO John O’Shaughnessy said that 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.
"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 US customers in this all-important segment of the market," O’Shaughnessy added.
Matrix Surgical USA’s Omnipore customized surgical implants are patient-specific devices derived from CT scan data.
The surgical implants are indicated for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. Additionally, they are intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
The company, which has been marketing its customized surgical implants in Europe, is currently seeking additional regulatory approvals in other countries across the globe.