Home » Stryker Receives 510(k) Clearance for Implantable Fracture Reduction Device
Stryker Receives 510(k) Clearance for Implantable Fracture Reduction Device
The FDA granted Stryker’s SpineJack implantable fracture reduction system 510(k) clearance for use in reducing osteoporotic vertebral compression fractures.
The SpineJack system had better results versus balloon kyphoplasty (BKP) during the Sakos clinical study, and showed improvements on the visual analog scale of pain and the Oswestry disability index.
After the titanium implant is inserted and expanded, the restored vertebral body is stabilized by adding PMMA bone cement at low pressure. It is available in three sizes to adapt to different vertebral body sizes.
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