Ellipse Technologies receives FDA clearance for limb lengthening system

Ellipse Technologies Inc. received FDA marketing clearance for the Precice 2 Intramedullary Limb Lengthening System in the United States for femoral or tibial limb lengthening. According to a company press release, the system can be used to correct limb inequality caused by congenital shortening, post-traumatic fractures and other conditions that result in leg shortening.

The Precice 2 system introduces a non-modular intramedullary design to simplify its implantation and provides increased nail length and distraction range options to better optimize treatment options. This system includes a new smaller diameter nail which will address a large segment of patients whose anatomy is too small for the original, larger Precice nails.

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