Safe Orthopaedics Gains CE Mark for Hickory Pedicle Screw

By Julie A. Vetalice

Safe Orthopaedics Gains CE Mark for Hickory Pedicle Screw

Safe Orthopaedics obtained approval under the CE Mark for Hickory to treat pathologies requiring pedicle screw fixation. Global launch is slated for 2022.

Hickory is the latest addition to the SteriSpine™ PS range that is designed to improve bone anchorage in osteoporotic patients. With a new thread design, Hickory is more securely fixed into the vertebral pedicle and reduces the risk of instability due to reduced bone quality.

This regulatory milestone comes on the heels of CE Mark approval for Sycamore, a new treatment for patients with one or more osteoporotic fractures.

Pierre Dumouchel, President and CEO of Safe Group, said, "In accordance with the new European Medical Devices Regulation, we are launching a study in Germany and preparing the global launch of Hickory in 2022. Hickory is the second project after Sycamore from our Safe Group consolidation, designed by Safe Orthopaedics and produced by Safe Medical, and is part of our plan for accelerated innovation and double-digit commercial growth.”

Product Labels: Spinal Fusion

Tags: CE Mark, Regulatory