FDA Clears New Size of Osseoflex Steerable Balloon

Santa Rosa, Calif.-based Osseon LLC has earned U.S. Food and Drug Administration 510(k) clearance for the new addition to its steerable, articulating vertebral augmentation product line, the Osseoflex SB 2 ml steerable balloon.

The steerable Osseoflex SB balloon is designed to navigate with precision, accuracy, and control within the vertebra to create a central cavity across the sagittal midline. The addition of a smaller 2 ml balloon size to the product line will accommodate treatment of compression fractures of smaller vertebra in the thoracic and lumbar spine, according to the company.

Osseon makes medical devices for minimally invasive treatment of vertebral compression fractures.