FDA updates recommendations for titanium-based intramedullary limb lengthening system
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Key takeaways:
- The FDA updated its recommendations for the Precice intramedullary limb lengthening system.
- The FDA announced that it will continue to monitor the biocompatibility risks associated with titanium-based devices.
The FDA released an update to its recommendations for the NuVasive Precice intramedullary limb lengthening system, according to a press release.
“The update is to ensure health care providers are aware of the current indications and the instructions for use for the [intramedullary limb lengthening] IMLL system,” members of the FDA wrote in the release. “We are reminding health care providers that the device should be removed after 1 year.”
According to the release, the Precice IMLL system is intended for use in patients aged 18 years and older for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, nonunion and bone transport of long bones.
For limb lengthening of the femur and tibia, the FDA recommended that the system is only used in patients aged 12 years and older.
Additionally, the Precice Freedom and Unyte devices should only be used in patients aged 18 years and older and two devices should not be implanted in a patient simultaneously, according to the release.
“The FDA will continue to keep health care providers and the public informed if significant new information becomes available,” members of the FDA wrote in the release.
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