The Affix system is approved to clamp spine grafts in place during surgery. The FDA’s letter stems from an inspection last fall, which found that NuVasive had branded its Affix system as useful for interbody fusion procedures, a use not approved by the FDA. “This constitutes a new intended use and a new 510(k) is required,” the letter stated.
The device company has 15 days to respond to the FDA with a plan to rectify the situation. Failure to promptly correct the violations could result in regulatory action, such as seizure, injunction and monetary penalties.
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