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# Zimmers’ Spinal Tether OK’d for Idiopathic Scoliosis
- URL: https://www.fdaweb.com/zimmers-spinal-tether-okd-for-idiopathic-scoliosis/
- Published: 2019-08-16T12:00:00.000Z
- Updated: 2026-09-15T01:44:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144784

FDA has approved Zimmer Biomet Spine’s The Tether – Vertebral Body Tethering System, the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. It is intended to treat children whose spinal curves are approaching or have reached the range where surgical treatment is an option, an [agency release](http://s2027422842.t.en25.com/e/es?s=2027422842&e=245204&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=19046719d45d483793010a538a464b94&elqaid=9164&elqat=1&ref=fdaweb.com) says.  

Idiopathic scoliosis is a sideways curvature of the spine whose cause is unknown. About 6,800 patients in the U.S. each year will develop progressive curvatures that do not respond to bracing. For these patients, spinal fusion surgery is often used to permanently stabilize and correct spinal curvatures, but it restricts spinal motion and “may have long-term complications such as pain, arthritis and future spinal deformities, which could require additional surgical treatment,” FDA says.

The Tether provides an alternative for patients with idiopathic scoliosis who don’t respond to bracing. As a patient grows, the device is designed to continue to correct the curvature while maintaining a fuller range of motion when compared to spinal fusion procedures, the agency says. It includes anchors and vertebral body screws that are placed into the same side of each vertebra in the curved section of the spine through an incision on the side of the chest. A flexible tether cord is connected to the screws, and tension is applied to the tether during surgery to partially correct the curve, it says. Over time, the tether slows growth on the curved side of the spine and promotes growth on the opposite side.

Zimmer is partnering with the Harms Study Group to develop a patient data registry to help assess the device’s long-term performance.