Alphatec earns FDA clearance for pedicle screw system: 3 highlights

Alphatec received FDA 510(k) clearance for its OsseoScrew System.

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Here are three highlights:

1. The expandable pedicle screw system is designed to restore the spinal column in elderly patients with advanced stage tumors in the thoracic and lumbar spine.

2. Alphatec designed the system to be implanted into the pedicle and then expanded after implantation.

3. The OsseoScrew System is intended to increase pullout and holding strength. The company found the system improved fixation in the bone-implant interface by 29 percent compared to conventional pedicle screws.

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