Stryker Gains FDA Clearance for SpineJack Fracture Reduction

By Julie A. Vetalice

Stryker received FDA 510(k) clearance to market the SpineJack® implantable reduction system to treat osteoporotic vertebral compression fractures. Limited launch will occur throughout the end of 2018.

SpineJack comprises three titanium implants of differing diameters that address 95% of VCFs and all patient morphologies. The 30-minute, minimally invasive x-ray guided procedure is intended to support patient discharge shortly after surgery.

Stryker acquired the technology with its purchase of Vexim in 2017. SpineJack has been commercially available in Europe since 2008, with >70,000 units implanted worldwide.

Sources: Stryker; ORTHOWORLD Inc.

 

Product Labels: Vertebroplasty/Kyphoplasty

Tags: 510(k) Clearance, Regulatory