Alphatec Gains FDA Clearance for OsseoScrew

By Julie A. Vetalice

Alphatec received FDA 510(k) clearance to market the OsseoScrew® expandable pedicle screw.

The device is intended for use in elderly patients with advanced tumors in the thoracic and lumbar spine. Clinical results indicate that OsseoScrew improved fixation at the bone/implant interface by 29% vs. conventional pedicle screws, with performance comparable to cemented fenestrated screws without the risk associated with cement leakage.

Source: Alphatec Holdings, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory