FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Zimmer Biomet’s Spinal Tether Grabs FDA Clearance

Aug. 20, 2019

Zimmer Biomet received 510(k) clearance for its spinal tether, a device designed to correct pediatric scoliosis.

The tethering device uses a flexible cord instead of metal rods to straighten the user’s spine while still allowing growth for the inside of the curve.

When used in “appropriately selected patient, the results are dramatic with respect to curve control and maintenance of a mobile spine,” said Amer Samdani, a doctor with the Philadelphia Shriners Hospital for Children.

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