Stryker received FDA 510(k) clearance for its SpineJack Implantable Fracture Reduction System.
Here are four things to know:
1. The SpineJack system is indicated for osteoporotic vertebral compression fracture reduction.
2. The system is available in three sizes to accommodate different vertebral body sizes. The SpineJack titanium implant is inserted and expanded, and poly(methyl methacrylate) bone cement is injected at low pressure in order to stabilize the restored vertebral body.
3. The SpineJack system has been commercially available in Europe since 2008, and more than 70,000 units have been implanted across the globe.
4. Stryker will execute a limited launch of the system for the remainder of 2018.