Prosthesis, internal, ear/nose/throat, synthetic

Intended purpose

StarPore is a range of anatomically shaped surgical implants manufactured from porous high-density polyethylene (HDPE). The star (“Star-”) shaped particles create an interconnecting porous (“-Pore“) architecture resembling trabecular bone. The implants are provided sterile and intended for single-use. StarPore is manufactured from medical grade HDPE (an electrically nonconductive and nonmagnetic polymer) and is suitable for use during Magnetic Resonance Imaging (MRI). StarPore Craniofacial Implants are intended for permanent implantation by surgeons on patients who need restoration or augmentation of bony contour in craniofacial defects. INTENDED USE StarPore Craniofacial Implants are intended for the restoration or augmentation of external bony contour in craniofacial defects. These devices are not intended to come into contact with the central nervous system including the meninges.