Stryker Announces 510(k) Clearance of SpineJack® Implantable Fracture Reduction System

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Stryker announced that it has received FDA 510(k) clearance to market the SpineJack Implantable Fracture Reduction System.  The SpineJack system is indicated for use in the reduction of painful osteoporotic vertebral compression fractures.

In the SAKOS clinical study, the SpineJack system demonstrated superiority to balloon kyphoplasty (BKP) for the endpoints of freedom from adjacent level fracture and midline vertebral height restoration.  The SpineJack system also showed substantial and sustained improvement in both pain (VAS) and function (Oswestry Disability Index) over BKP.

Available in three sizes to accommodate different vertebral body sizes, the SpineJack titanium implant is inserted and expanded, and PMMA bone cement is injected at low pressure to stabilize the restored vertebral body.

The SpineJack system has been commercially available in Europe since 2008 and over 70,000 units have been implanted worldwide.  The company plans to execute a limited launch of the device for the remainder of 2018.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.


For Further Information

More on the spinal implants and VCF market in the US can be found in a series of reports published by iData entitled the US Market Report Suite for Spinal Implants and VCF. This report covers the following market segments: traditional cervical and thoracolumbar fixation devices, interbody devices, motion preservation devices, vertebral compression fracture (VCF) treatment, and spinal instrumentation.

The iData series on the market for spinal implants and VCF covers the U.S., Latin America (Brazil, Mexico, Argentina), and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about spinal implants and VCF market data or procedure data, register online or email us at for a US Market Report Suite for Spinal Implants and VCF brochure and synopsis

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