Clinical Research Directory

Inclusion Criteria: * Patient must be 18 years of age or older * Patient must have a distal humerus fracture requiring surgical intervention and be eligible for fixation by locking plate and screws * Patient must have a fracture pattern requiring a minimum construct of the medial and posterolateral plates. Additional fragment plates may be used in addition as necessary. * Unilateral or bilateral fractures. * Patient must be capable of understanding the doctor's explanation, following the doctor's instruction, is able to and willing to complete the protocol required followup. * Patient must have a signed IRB-approved informed consent. Exclusion Criteria: * Active infection * Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone * Foreign body sensitivity where material sensitivity is suspected; testing is to be completed prior to implantation of the device. * Uncontrolled diabetes mellitus (e.g., investigator judgment or HbA1c above locally accepted surgical threshold). * Current systemic immunosuppressive therapy or known immunodeficiency that may impair healing or increase infection risk. * Morbid obesity (BMI ≥ 35 kg/m²) where, in the investigator's opinion, surgical risk or outcome assessment may be compromised. * Patient known to be pregnant or breastfeeding. * Patient is a current alcohol or drug abuser. * Severe psychiatric disorder or cognitive impairment interfering with informed consent, protocol compliance, or follow-up. * Likely problems with maintaining follow-up program (e.g., patient with no fixed address, long distance, plans to move during the course of study). * Not expected to survive the duration of the follow-up program. * Revision procedure at the target site (i.e., not a primary procedure).