The 510(k) Process and DePuy Synthes’ Defective Attune Knee System

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The 510(k) Process and DePuy Synthes’ Defective Attune Knee System

The DePuy Synthes’ Attune Knee System has a high rate of failure. Merkel & Cocke, P.A. is currently accepting cases on behalf of clients who have sustained injuries from the defective Attune knee replacement system. We invite you to contact us to learn more.

Medical devices such as the DePuy Synthes’ Attune Knee System need to be approved by the Food and Drug Administration (FDA). The FDA considers approvals according to the requirements of the federal Food, Drug, and Cosmetic Act (FD&C Act). Generally, medical devices need Premarket Approval by the FDA. Premarket approval is a rigorous scientific and regulatory review of the safety and effectiveness of the medical device. Premarket approval is the toughest type of approval process. Approval can take years and normally requires numerous showings that the product met different scientific tests.

In some cases, a premarket approval is not required for a medical device. Instead, the developer/maker of the device can seek approval through the 510(k) process. This process essentially requires that the applicant for FDA approval show that their medical device is significantly similar to other medical devices that have already been approved. Once approved, the device can be sold and used. The DePuy Synthes’ Attune Knee System used the 510(k) approval process.

The 510(k) process

Any legally marketed device can serve as the predicate – the previously approved medical device. The main test the applicant must meet is to show that their device is “substantially equivalent” to the predicates. The FDA should conduct an FDA quality systems inspection after 510(k) approval is obtained.

Substantial equivalence, according to the FDA, means that the new medical device is “at least as safe and effective as the predicate.” This means the new device should:

  • “have the same intended use as the predicate; and
  • have the same technological characteristics as the predicate; or
  • have the same intended use as the predicate; and
  • have different technological characteristics and does not raise different questions of safety and effectiveness; and
  • the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device”

The Attune knee replacement system went through this 510(k) process, which means there were never any human trials. Furthermore, many of the Attune system’s predicate devices – most of which were produced by DePuy itself – have also been recalled or pulled from the market because of systemic failures.

In other words, the predicate devices were dangerous – and the FDA still allowed them to be named as predicate devices, this giving DePuy a way to bring its faulty systems to market even faster.

Medical devices that fail cause extended pain and suffering. Often corrective surgery can just make a bad situation even worse. All surgeries have risks. If any medical device used to help your pain is making you feel uncomfortable or worse than before your surgery, our product liability lawyers are ready to help you get justice. We understand why devices are defective and work with safety professionals, physicians, and others to show a product shouldn’t have been marketed.

For help with all medical surgeries that fail, call Merkel & Cocke, P.A. at 662-799-1633 or use our contact form to speak with a strong advocate. Our Mississippi offices are in Jackson, Clarksdale, and Oxford. We represent patients and families throughout Mississippi, including in Tupelo and the Gulf Coast Region. We also file product defect and medical device claims in Tennessee and Arkansas.

 

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