Safe Orthopedics today said it received CE mark approval for its Hickory screw for osteoporotic patients.
Hickory is a new pedicle screw in the France-based company’s SteriSpine PS range that improves bone anchorage in osteoporotic patients.
The company designed Hickory to be securely fixed into a vertebral pedicle to reduce the risk of instability from reduced bone quality in osteoporotic patients. It has a fenestrated, variable-thread screw that reduces the number of instrumented levels and supports less invasive procedures, according to the company.
“The growing challenge of operating on osteoporotic patients has been defined by the inability to achieve an appropriate pedicle screw construct. That problem is not only seen in osteoporotic situations but also in cases with metastatic instabilities where the screw and rod system will not be supported by bony fusion over time. Having tried many screw designs for these indications, I have found that a variable-thread design provides improved haptic feedback as well as superior anchorage in the pedicle and in the vertebral body, where fenestrations in the screw also allow for additional fixation by augmentation. In my experience, such a construct reduces the risk of screw loosening dramatically,” Jens Richolt, a spinal surgeon in Germany, said in a news release.
Safe Orthopedics is launching a study of the screw technology in Germany and expects to launch the device worldwide by 2022.
“We thank Dr. Jens A.Richolt for his support in this project and are proud to announce the CE marking of this new Hickory screw, to complete our SteriSpine PS product range in order to offer the maximum number of solutions to our customers,” president and CEO Pierre Dumouchel said. “In accordance with the new European medical devices regulation (MDR), 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 Orthopedics and produced by Safe Medical, and is part of our plan for accelerated innovation and double-digit commercial growth.”