Orthopedic & Fracture Appliances, Including Artificial Joints

No. External braces are typically Class I or Class II devices with lower regulatory burdens, while implantable artificial joints are generally Class II or Class III devices requiring 510(k) clearance or, in some cases, premarket approval (PMA). Both must originate from FDA-registered establishments, but the premarket authorization pathway and post-market surveillance requirements differ significantly. Importers should verify the specific device class and authorization status before entry.

Shipments should be accompanied by documentation identifying the device name, model number, FDA 510(k) or PMA number, the name and FDA registration number of the foreign manufacturer, and the intended use. FDA may detain shipments for examination if the device is not recognized in its databases or if labeling is non-compliant. Working with a licensed customs broker experienced in medical device imports is strongly recommended.