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Stryker announces FDA clearance of implantable fracture reduction system

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Stryker announced it received FDA 510(k) clearance of its SpineJack Implantable Fracture Reduction System, which it unveiled at the North American Spine Society Annual Meeting.

The SpineJack system is indicated for use in the reduction of osteoporotic vertebral compression fractures. According to a company press release, a clinical study found use of the SpineJack system showed significant improvement in both pain and function compared to balloon kyphoplasty.

Since 2008, the system has been commercially available in Europe and more than 70,000 units have been implanted in worldwide, according to the release. Stryker plans a limited U.S. release of the SpineJack for the remainder of 2018.

Reference:

www.stryker.com