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Objective: This study analyzes indications and outcomes of premaxillary setback (PS) and presents an algorithm for its use in patients with bilateral cleft lip and/or palate (BCL ± P)., Design: Retrospective review., Setting: Children's Hospital Los Angeles., A retrospective review was conducted evaluating patients with BCL ± P undergoing lip repair from 2003-2023. Patients were categorized as undergoing repair with (BCL + PS) or without (BCL-PS) simultaneous PS. Presurgical nasoalveolar molding (NAM), indications for PS, timing of surgery, and complications were collected., Interventions: BCL with PS, BCL + PS., Main Outcome Measures(s): Primary outcomes included rates of postoperative complications and revision surgeries. Secondary outcome was the need for orthognathic surgery to correct midface hypoplasia in patients at least 14 years old at their most recent follow-up., Results: Of 1193 patients, 262 met inclusion criteria. One hundred forty-nine patients (56.9%) were referred for NAM. Fifty-one patients (19.5%) underwent PS during primary BCL repair. Patients who failed repositioning of the premaxilla following presurgical NAM (n = 12) were not candidates for NAM (n = 31) or presented late with a protruding premaxilla (n = 8, 12.977 ± 8.196 months) underwent PS. Median age at surgery was 4.29 months. Complications included wound dehiscence (n = 3) and abscess formation (n = 2). No premaxillary necrosis occurred. Overall revision rates were 9.9%. Of 41 patients over 14 years old, 53.6% needed orthognathic surgery. BCL + PS had comparable rates of wound dehiscence (2.0% vs 4.0%; P  = .790), lip revisions (7.8% vs 10.4%; P  = .770), and orthognathic surgery (50.0% vs 56.3%; P  > .999)., Conclusion: PS is a safe and effective method to facilitate BCL repair in patients who are not candidates for NAM., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.