Safe Orthopaedics, based in Eragny, France, received FDA clearance to market its new implant for traumatic spinal injuries in the United States.
Here are five key notes:
1. The One-Step System implant aids with fracture correction and spine stabilization at the same time.
2. Designed for thoraco-lumbar trauma injuries treated through open or MIS surgery, the implant is a screw mechanism that provides vertebral fracture reduction.
3. The One-Step System is intended to be used only once, coupled with single-use surgical instruments.
4. Surgeons used the implant in more than 20 operations in France and the Netherlands.
5. Safe Orthopaedics will showcase the product at the North American Spine Society meeting in Chicago.