Before an orthopedic company can sell a device in America, the device must first receive FDA approval. Stryker obtained FDA approval for the Rejuvenate hip system in June of 2008 and received approval for the ABG II System in November of 2009. Stryker received FDA approval for each implant under what’s known as 510(k) Premarket Notification, also known as 510(k) clearance.
Under 510(k) clearance, the device manufacturer does not have to show that the device has been used safely in clinical trials. Instead, the manufacturer needs to show that the proposed device is substantially equivalent to a device that is already on the market. This approval process has proved controversial devices as many critics have argued that metal-on-metal devices have not received adequate scrutiny before mass marketing. Rather, critics contend, the process allows devices that are considered “substantially equivalent” to come to market even though they have some novel and inadequately tested features.