FDA Reiterates NuVasive Device Indications

FDA has issued a letter to healthcare providers to ensure they are aware of the current indications and instructions for use for the NuVasive Precice Intramedullary Limb Lengthening (IMLL) system, including Precice Short. An online update reminds providers that the IMLL device should be removed after one year.

“Precice devices are implants intended to lengthen the limb, shorten or compress the limb, or transport segments of long bones,” the notice says. “Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism.”

FDA says it currently is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. It says that as NuVasive continues to investigate the root causes of issues with stainless steel Precice devices, it also is looking into how those issues may relate to titanium-based devices.