FDA WARNING_LETTER - DePuy Orthopaedics, Inc.

On August 19, 2010, the FDA issued a Warning Letter to DePuy Orthopaedics, Inc. for marketing the TruMatch Personalized Solutions System and the Corail Hip System without required marketing clearance or approval.

The TruMatch Personalized Solutions System was found to be adulterated under section 501(f)(1)(B) of the Act and misbranded under section 502(o) because DePuy had not obtained premarket approval (PMA) or investigational device exemption (IDE), nor had they submitted a 510(k) notification.

For the Corail Hip System, while a 510(k) (K042992) was cleared for total hip arthroplasty, the firm's website promoted unapproved claims such as "Proprietary HA coating for initial osteointegration and fixation" and "promotes osteointegration for excellent fixation." These claims represent a major change in intended use requiring a new premarket notification (21 CFR 807.81(a)(3)(ii)). Consequently, the Corail Hip System was deemed adulterated under section 501(f)(1)(B) and misbranded under section 502(o) for failure to submit a new 510(k) for these changed uses.

The FDA requested DePuy immediately cease marketing the Corail