Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware

Inclusion Criteria: * Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization prior to any study related procedures. * Subjects can be any gender, but be between (and including) 18 and 80 years of age * Subject is scheduled for a cranial procedure that requires the creation of a bone flap or replacement of a bone flap (i.e., cranioplasty) * Subject is scheduled for a cranial procedure in the supratentorial location. * Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests. * Pre-operative CT scan for craniotomy patients must be less than or equal to 0.625 mm slice thickness and pixel spacing. It shall include the skull in native condition near the planned flap site DICOM export must be thin sliced reconstruction in the bone window. Intra-Operative Inclusion Criteria: • Width of craniotomy kerf line \< 3mm for more than 75% of the bone flap border. Exclusion Criteria: * Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy is not exclusionary). * Subject requires a craniectomy (the bone flap is not replaced during the current surgery). * Subject has had radiation treatment to the surgical site within the past year, or standard fractionated radiation therapy was planned within 2 weeks post index-procedure. (Note: stereotactic radiosurgery…