FDA Warns DePuy Over Custom Devices
BY LAUREN UZDIENSKI, JANUARY 18, 2012
An FDA warning letter sent to DePuy in December alleges that the company has been manufacturing custom hip and knee components in violation of FDA regulations. Custom devices are intended to be manufactured for one patient, and such devices are generally exempt from market clearance.
In the letter, the FDA states that DePuy's devices may not meet the agency's definition of "custom" because devices intended as custom may have been replicated for other physicians. FDA Compliance Director Steven Silverman writes, "The fact that final specifications are tailored to match a patient's anatomy does not preclude a clinical study or submission of a marketing application for the devices." Reports have stated that the company is planning to stop offering custom devices.
Affected product lines include the PFC Sigma Knee System, the Agility Total Ankle Prosthesis, Global humeral stems and TriFlange Acetabular Cups as well as additional total hip components.
Custom devices and instruments have emerged as a gray zone for regulators. ConforMIS was the first company to receive 510(k) clearance to market its iTotal CR Knee Replacement System in early 2011, after a yearlong review period. In 2010, Biomet received an FDA warning letter regarding its Signature customized cutting guides for total knee replacement, and the company temporarily suspended marketing of the device until it was FDA-cleared in February of 2011. Stryker received 510(k) clearance for a similar product in May, the Shapematch, which was acquired in 2009 from Otismed.
