The 510(k) process is a process which the United States Food and Drug Administration (FDA) uses to approve many Class II medical devices sold in the United States. During this process the FDA does not "approve" medical devices; they "clear" them for availability on the market. After a device gains 510(k) approve it will be given a 510(k) number. The number will not expire after it is given. The companies must still comply with all FDA regulations to continue to sell their products in the United States.
Applicants asking for 510(k) clearance ask the FDA’s examiners to clear their device because it is“substantially equivalent” to an existing device. The FDA has started to reject a bigger number of 510(k) applicants since June, 2011. The FDA has also tightened up some parameters that a device can be approved. In the past, applicants frequently pointed to as many as 30 predicate devices. From now on however, the FDA suggests that it will only consider on main and one secondary predicate device.
The tightening of the FDA reigns of the 510(k) process could be caused by several devices approved by the 510(k) process have become the topic of several medical lawsuits. One particular device, the Wright Profemur Z hip implant, has recently come under scrutiny because of its unusually high 11.2% failure rate within 3 years of implantation. The most common complaint of the Profemur Z hip implant is that it is prone to breaks, especially in the femoral neck portion.
Patients who have had their Profemur Z implant fail will have to get further surgeries to fix the broken implant. The way Wright was able to get the Profemur Z implant approved through the 510(k) process was it claimed the implant was already similar to other hip replacement systems on the market. Wright was able to get 510(k) approval and was able to skip the FDA required human trails.Because of this high failure rate many patients have begun to file lawsuits against Wright.
URL References:
http://www.timesunion.com/business/press-releases/article/New-Lawsuit-filed-on-Wright-Profemur-Hip-3401646.php
http://www.embedded.com/electronics-news/4370059/FDA-s-510-k--gets-tougher--more-predictable
