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Medical Devices / Submissions and Approvals

Matrix Surgical’s OmniPore Implants Cleared for Marketing

Oct. 22, 2018

Matrix Surgical USA received 510(k) clearance from the FDA to market its OmniPore DUROMAX surgical implants for non-weight-bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.

The orbital implant builds upon the company’s previously cleared high-density polyethylene craniofacial implant platform by adding titanium inside the porous polyethylene framework. The titanium retains shape after manipulating by hand and is radiopaque on post-operative computer tomography (CT) scans, unlike regular porous polyethylene implants.

Additional variants are currently in development and are expected to be launched in early 2019 in markets where the company has regulatory clearances.

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