June 28, 2023

The U.S. Food and Drug Administration (FDA) is providing an update to information and recommendations for the NuVasive Specialized Orthopedics’ (NuVasive) Precice Intra-medullary Limb Lengthening (IMLL) system, which includes Precice Short. 

In March 2023, NuVasive received FDA 510(k) clearance for the expanded use of the Precice IMLL system (including Precice Short) for limb lengthening of the shin bone (tibia) and thigh bone (femur) in patients greater than 12 years old.  The update is to ensure health care providers are aware of the current indications and the Instructions for Use for the IMLL system.  We are reminding health care providers that the device should be removed after one year.

The FDA continues to monitor for adverse events related to potential biocompatibility concerns with titanium-based NuVasive Precice devices, including:

• Precice IMLL (including Precice Short)
• Precice Freedom
• Precice Unyte

Recommendations

• Read and follow the Instruction for Use for Precice devices:
  • Be aware that Precice Intra-medullary Limb Lengthening system (including Precice Short) is intended for use: 
    • in patients 18 years and older: for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, nonunions, or bone transport of long bones use and 
    • in patients greater than 12 years old: for limb lengthening of the femur and tibia.
  • Be aware that Precice Freedom and Unyte devices are intended for use only in patients 18 years and older.
  • Do not implant these Precice devices in patients under 50 pounds or over the maximum patient weight described in the instructions for use. 
  • Do not implant more than two Precice devices in a patient at once. 
  • The device should be removed after one year.
• For care of patients who currently have one of these devices and weigh less than 50 pounds or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. This can minimize the potential for biocompatibility risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment.

Note: Stainless steel-based Precice devices (Bone Transport, Plate, Stryde) remain recalled from the U.S. market due to adverse events related to potential biocompatibility concerns, and should not be implanted. Please continue to follow the actions in NuVasive’s recall notification.

Background

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

At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices.

FDA Actions

The FDA continues to work with NuVasive to:

• Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients.
• Ensure patients with a Precice device continue to receive appropriate follow-up monitoring.

The FDA will continue to keep health care providers and the public informed if significant new information becomes available.

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. 

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device

The table below describes the UDI information for titanium-based NuVasive Specialized Orthopedics, Inc. Precice devices:

For the full Device Identifier number, please refer to the list provided by NuVasive Specialized Orthopedics, Inc. 

For more information on UDI, please visit Unique Device Identification System (UDI System).

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices.

• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).