Zavation commenced launch of its Facet Screw and Sacroiliac (SI) Screw systems.
The fenestrated, cobalt chrome alloy-based Facet Screw is implanted from the posterior approach, and can offer both fusion and fixation. The implant is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
The titanium alloy-based SI screw, which received 510(k) clearance in March, is designed to stabilize the sacroiliac joint. It is available in multiple lengths and in cannulated or smooth shank versions to accommodate variations in patient anatomy, with bone growth windows along the body of each screw. A low-profile screw head is intended to prevent soft tissue irritation.
Zavation’s portfolio of spinal hardware products covers areas including thoracolumbar, cervical, interbody fusion and minimally invasive surgery. The company has 22 products listed in the FDA 510(k) database.
In 2015, Zavation entered into a co-development partnership with SpineGuard to integrate SpineGuard’s DSG™ (Dynamic Surgical Guidance) technology into pedicle screw systems. The DSG technology is a combination of a bipolar sensor and pedicle screw, which allows the surgeon real-time guidance and the ability to insert the screw into a vertebra without drilling a pilot hole. U.S. commercialization of DSG began in early 2017.