Ultrahigh Molecular Weight Polyethylene Guidance

FDA has issued a draft guidance, Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, to assist industry members who submit orthopedic devices using ultrahigh molecular weight polyethylene material to determine the appropriate information and testing to submit in 510(k)s, de novo requests, PMA applications, HDEs, and IDEs. The guidance addresses the characterization and testing of orthopedic devices that use UHMWPE materials such as conventional UHMWPE, highly crosslinked UHMWPE, and highly crosslinked UHMWPE containing vitamin E. “This document outlines the information we recommend you include in a submission to FDA to characterize the UHMWPE material (e.g., material description, sterility, biocompatibility, mechanical properties, and chemical properties,” it says.

Recommendations in the document are applicable to Class 2 and 3 devices intended for orthopedic applications.