Devices

Orthopedic Device UHMWPE Guidance

FDA has issued a guidance, Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, to be used by members of industry who submit applications for orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) material. The document is intended to assist sponsors in determining the appropriate information and testing to submit in 510(k)s, de novo requests, PMA applications, HDEs, and IDEs for orthopedic devices that contain UHMWPE.

The guidance addresses the characterization and testing of UHMWPE materials used in orthopedic devices. The materials include UHMWPE, highly crosslinked UHMWPE, highly crosslinked UHMWPE containing antioxidants, and non-conventional UHMWPE. “This document outlines the information we recommend you include in a submission to FDA to characterize the UHMPWE material (e.g. material description, sterility, biocompatibility, mechanical properties, and chemical properties),” FDA says. “The recommendations in this document are applicable to Class 2 and Class 3 devices intended for orthopedic applications, including spinal devices, which contain UHMWPE.”

The guidance includes an Introduction, Scope, Types of UHMWPE Materials Used in Implantable Orthopedic Devices, Material Processing and Characterization, Biocompatibility, Shelf Life and Packaging, and two appendices.

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