NuVasive receives FDA 510(k) clearance, CE mark for Precice Bone Transport System — 4 insights

Spinal Tech

NuVasive's Precice Bone Transport System received FDA 510(k) and European CE mark approval.

What you should know:

1. The Precice system is an all-internal system used for segmental bone loss treatment in the tibia and femur.

2. The Precice system compliments NuVasive's Specialized Orthopedics' offerings.

3. Tucson-based University of Arizona College of Medicine professor J. Tracy Watson, MD, called the technology a "game-changer."

He said, "Patients who undergo a bone transport procedure due to trauma, tumors or infection are already dealing with significant issues regarding their condition, and the extreme time commitment it takes to reconstruct these significant bone defects. To be able to offer a treatment option that allows them to avoid many of the traditional complications and physical challenges of dealing with an external fixation system that is on their limb for an extended period of time is a significant development."

4. NuVasive plans to launch the Precice system commercially in the third quarter of 2019.

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