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The Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone).

Customized Craniofacial Implant (CCI) and Customized Skull Implant (CSI) is an individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton (orbital rim, zygoma, & adjacent bone), ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long. A Customized Skull Implant (CSI) is intended to fill a bony void or defect area in a specific patient's skull whereas a Customized Craniofacial Implants (CCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, which are both considered load bearing areas of the facial region of the skull. The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific Base Implant that are used to support the base implant in the bony void or defect area while providing for a "Precise Fit". The single patient use base implant is (1) fabricated from a billet block of natural implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer using the patient's CT Scan imaging data, (2) provided clean but non-sterile for steam sterilization prior to implantation at a hospital or surgical site with neurosurgery capabilities, and (3) attached to the native bone using commercially available cranioplasty hardware and fasteners. The additional features listed below are additional design elements that may be added to the Base Implant and Base Implant with Perfusion Holes, as requested by the Physician. The Base Implant, as defined above (as previously cleared on K103582 and K121755).