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StarPore™ implants are intended for the restoration of bony contour in craniofacial defects. StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects.

StarPore™ (previously cleared as PoreStar™ Patient Specific Implants) 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). The purpose of this Traditional 510(k) submission is to add "off-the-shelt" implant options to the StarPore™ product line. These off-the-shelf implants would provide surgeons the options of various sizes of implants which, unlike the predicate, would not be individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. Instead, the subject implants would be offered in various off-the-shelf sizes and shapes which could then be cut by the prescribing surgeon intra-operatively to create an anatomically matched patient specific design. StarPore™ is intended for single use only and is provided sterile, using ethylene oxide gas.