Thermal Spray Coatings on Orthopedic Devices: When and How the FDA Reviews Your Coatings

Thermal spray coatings have been commonly applied on medical devices for various reasons, e.g., surface roughening, biological fixation, and similarity of chemical composition to bone minerals. Generally, to introduce a thermal spray-coated device to the US market, a premarket review of the coated device is necessary by the US Food and Drug Administration (FDA). This article aims to improve understanding regarding FDA review of thermal spray coatings in orthopedic medical device marketing applications and expectations for information to be submitted as part of this process. While different thermal spray technologies and materials have been used for coatings on medical devices, thermal spray coatings often seen by the FDA on orthopedic devices include plasma-sprayed titanium (Ti) coatings and hydroxyapatite (HA) coatings as well as Ti/HA dual coatings. The coated devices are mostly metals (e.g., Ti alloy, cobalt-chromium alloy, stainless steel alloys) and some polymers (e.g., polyetheretherketone). The FDA does not clear or approve individual coatings or materials; rather, coatings and materials are evaluated as part of the final, finished medical device in the context of the specific device technological characteristics and intended use. The FDA has two current guidance documents for orthopedic implants with modified metallic surfaces and hydroxyapatite coatings, which outline the FDA’s recommendations for full characterization and testing of these two types of coatings, respectively. Additionally, the standards organizations (e.g., ISO and ASTM) have developed many materials and testing standards for these coatings, some of which are recognized by the FDA. It is helpful that the coating companies reference these standards for appropriate material/coating specifications, testing methods, and acceptance criteria. Depending on the intended use of the coated device, it is important that coating properties also address some items specific to that device type. Additionally, the impact of cleaning, sterilization, and packaging/shelf-life processes on the coating properties is also considered to ensure that the coated device is safe for its intended use.