Ellipse Technologies said it secured clearance from the FDA for its Precice 2 limb-lengthening system.
Irvine, Calif.-based Ellipse makes spinal and orthopedic devices. The devices are adjustable without an invasive procedure and mainly come in the form of remote-controlled implants.
The Precice 2 is an adjustable intramedullary nail used for limb lengthening of the femur and tibia. This newly-cleared model has a smaller diameter, at 8.5mm, addressing another class of patients whose bodies were too small for the original, according to a press release.
“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. We continue to work every day to apply our platform technology to address unmet needs in orthopedics and spine,” president & CEO Ed Roschak said in prepared remarks.