1. Scope

Keywords

Rationale

This standard is needed because there is currently no standardized method for evaluating initial fixation of shoulder humeral components. This proposed standard will establish a test method to ensure repeatability and comparability of results. This will be a short-term loosening test that can be used to compare to a predicate or as a pre-clinical assessment. The users will consist of: shoulder device manufacturers, independent test labs, researchers, and regulatory bodies.