Matrix Surgical Holdings, LLC dba Matrix Surgical USA

Matrix Surgical USA specializes in manufacturing OmniPore® porous high-density polyethylene implants. These implants are specifically designed for craniofacial reconstructive and aesthetic surgery, providing structural support and facilitating tissue integration in targeted anatomical areas. The devices are tailored for procedures requiring durable, biocompatible solutions in head and facial reconstruction.

Matrix Surgical USA is based in the United States, and all its devices, including the OmniPore implants, are manufactured in the USA. The company emphasizes domestic production to ensure compliance with regulatory standards and maintain quality control for its medical implants.

Matrix Surgical USA’s devices are listed in the EU’s eudamed database, which serves as the official registry for medical devices within the European Union. This registration reflects compliance with EU regulatory requirements, though individual device authorization depends on the specific regulatory pathway (e.g., CE marking) followed for each product.

The OmniPore implants fall under EU Class IIb classification, which applies to devices posing a moderate risk to patients. This classification requires stricter regulatory scrutiny, including clinical evaluations and conformity assessments, to ensure safety and performance before market authorization. The classification aligns with the implants’ intended use in reconstructive and aesthetic craniofacial surgery.