Inspections, Compliance, Enforcement, and Criminal Investigations
Depuy Orthopaedics, Inc. 8/19/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
AUG 19 2010
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
RE: TruMatch™ Personalized Solutions System
Corail® Hip System
Refer to GEN0901195 when replying to this letter.
Dear Mr. Floyd:
The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch™ Personalized Solutions System and the Corail® Hip System in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website, www.depuyorthopaedics.com. for the TruMatch™ Personalized Solutions System and the Corail® Hip System. The products are devices within the meaning of section 201(h) of the Act 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch™ Personalized Solutions System for sale, which is a violation of the law. Specifically, the TruMatch™ Personalized Solutions System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for investigational device exemptions (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution. as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Corail® Hip System
A review of our records indicates that we cleared a premarket notification (510(k)) for the Corail® Hip System, K042992, with an intended use for total hip arthroplasty "to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components." In addition, total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The non·porous Corail AMT Hip Stem is indicated for cementless use only.
However, a brochure on your website,
ESS%20STEMS/CORAIL%20AMT/DO Corail_AMT_ Design Rationale_ 0612-70-501r2.pdf, states the following claims about the Corail® Hip System:
• "Proprietary HA coating for initial osteointegration and fixation" (page 3);
• "Proprietary HA coating ... clinically demonstrated rapid trabeculae formation leading to rapid fixation," and "promotes osteointegration for excellent fixation" (page 4);
Promotion of this device for osseointegration (a.k.a. osteointegration), whether explicitly or implicitly (for example, through fixation claims that imply osseointegration). represent a major change or modification in the intended use of your device that require a new premarket notification. 21 CFR 807.81(a)(3)(ii). Because of these claims, the Corail® Hip System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section, 502(o) of the Act, 21.U.S.C. 352(o), because you did not submit to FDA a notification respecting the changes to the intended use of the device, as required by section 510(k) of the Act, 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii).
FDA requests that DePuy Orthopaedics, Inc. immediately cease marketing the Corail® Hip System for unapproved uses such as those described above. You should take prompt action to correct the violations listed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and lor civil money penalties.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations for the TruMatch™ Personalized Solutions System and the Corail® Hip System, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please include in your response a list all promotional materials for the Corail® Hip System containing claims for unapproved uses such as those described above, and explain your plan for discontinuing such claims.
Your response should be sent to:
Orthopedic and Physical Medicine Devices Branch
Office of Compliance
Center for Devices and
WO 66, Room 3676
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter please contact: Amy Skrzypchak at phone number (301) 796-5613 or email@example.com.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations, and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and