Objective: The aim of this study is to conduct a systematic review and meta-analysis on the performance of the WHO’s Fracture Risk Assessment (FRAX) instrument for predicting 10-year risk of Major Osteoporotic Fractures (MOF) and Hip Fractures (HF) in populations other than their derivation cohorts. Design: PubMed, Google Scholar, Embase, Cochrane Library, and MEDLINE were searched for the English-language literature from 2008 to 2015. Limiting our search to articles that analyzed only MOF and / or HF as an outcome, 7 longitudinal cohorts from 5 countries (USA, Poland, France, Canada, New Zeland) were identified and included in the meta-analysis. SAS NLMIXED procedure (SAS v 9.3) was applied to fit the Hierarchical Summary Receiver Operating Characteristics (HSROC) model for meta-analysis. Forest plot and HSROC plot was generated by Review Manager (RevMan v 5.3). Results: Seven studies (n=57,027) were analyzed to assess diagnostic accuracy of FRAX in predicting MOF. Using 20% as the 10-year fracture risk threshold, the mean sensitivity, specificity, and diagnostic odds ratio (DOR) along with their 95% confidence intervals (CI) are 10.25% (3.76% - 25.06%), 97.02% (91.17% - 99.03%) and 3.71 (2.73 – 5.05), respectively. For HF prediction, using 3% as the 10-year fracture risk threshold, six studies (n=50,944) were analyzed. The mean sensitivity, specificity, and DOR along with their 95% confidence intervals (CI) are 45.70% (24.88% - 68.13%), 84.70% (76.41% - 90.44%) and 4.66 (2.39 – 9.08), respectively. Conclusion: Overall, FRAX performs better in identifying patients who will not have a MOF or HF within 10 years. However, a substantial number of patients who developed fractures, especially MOF within 10 years of follow up, were missed by the baseline FRAX assessment using the 10 year intervention thresholds of 20% for MOF and 3% for HF.