3D Printed Medical Grade Ti-6AI-4V Osteosynthesis Devices Meet the Requirements for Tensile Strength, Bending, Fatigue and Biocompatibility

Description

The presentation features Alisdair MacLeod discussing the applications of 3D printing in orthopaedics, highlighting its history and the safety of certain devices. He shares his experience with the regulatory challenges faced during the submission of a personalized 3D printed plate for a clinical trial, noting that the device was inaccurately classified as a novel material despite not fitting that description. Alisdair describes the testing conducted, including strength and fatigue testing, and underlines that the regulators prioritize biological safety evaluations over material assessments. He also emphasizes the complexities of proving material integrity and cleaning processes amid regulatory scrutiny. After detailing the eventual approval for the clinical trial of a custom titanium alloy device, Alisdair showcases clinical images from early implementations. Following his presentation, Richie Gill addresses questions regarding regulatory differentiation between bespoke and standard implants, emphasizing the challenges encountered in proving compliance given the novel status of 3D printed materials. The session concludes with further inquiries about specific printing parameters and the overall material quality of the implants.

DOI: 10.1302/3114-221115

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