FDA Clears Ellipse’s New Version of Limb Lengthening System

Irvine, Calif.-based Ellipse Technologies Inc. has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Precice 2 intramedullary limb lengthening system. The original version of the Precice system was initially cleared in 2011. This new version, designed to correct limb inequality caused by congenital shortening, post-traumatic fractures, and other conditions that result in leg shortening, has been cleared for limb lengthening of the femur or tibia.

The Precice 2 system introduces a non-modular intramedullary design in order to simplify its implantation and provides increased nail length and distraction range options to better optimize treatment options. This system also includes a new smaller diameter (8.5 mm) nail intended to address a large segment of patients whose anatomy was too small for the original, larger Precice nail devices.

“The introduction of the Precice 2 system complements the early success of the Precice device with improved efficiency in the operating room and the larger range of patients with limb length inequality who can now be treated,” said Ed Roschak, President and CEO of Ellipse. “We continue to work every day to apply our platform technology to address unmet needs in orthopedics and spine.”

Surgeons Shawn C. Standard, M.D., head of pediatric orthopedics at the International Center for Limb Lengthening at Sinai Hospital in Baltimore, Md., and Dror Paley, M.D., director of the Paley Advanced Limb Lengthening Institute at St. Mary’s Medical Center in West Palm Beach, Fla., were the first surgeons in the United States to use the Precice 2 system.

“Previously, treatment options for patients with limb length inequality were very limited. The Precice system has dramatically impacted my practice over the last two years, and, with Precice 2, I expect even better results for my patients.” said Standard.

Paley added, “The Precice 2 system makes a great device even better and allows me to treat a wider spectrum of patients than before.”

The Precice 2 system has been granted FDA marketing clearance for limb lengthening of the femur or tibia. This system is designed correct limb inequality caused by congenital shortening, post-traumatic fractures, and other conditions that result in leg shortening.