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# FDA Approves Medtronic PMA for Prestige Cervical Disc
- URL: https://www.fdaweb.com/fda-approves-medtronic-pma-for-prestige-cervical-disc/
- Published: 2016-07-18T12:00:00.000Z
- Updated: 2026-09-14T21:15:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136206

FDA has approved a Medtronic PMA for the Prestige LP Cervical Disc for treating cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the neck’s C3-C7 segments. The device is designed to allow motion in the neck at the operated levels, unlike fusion surgery which does not preserve motion, the company says. Its low profile, ball-and-trough design moves in a range of motions, including bending, rotation, and translation.

Approval was based on data from two pivotal clinical trials involving 397 patients (209 investigational and 188 control patients) at 30 sites around the U.S. At 24 months, the Prestige LP patient group demonstrated statistical superiority in overall success compared to patients treated with a two-level anterior cervical discectomy and fusion, Medtronic says. “Overall success required a patient to meet all criteria for neurologic success, Neck Disability Index success, absence of serious, device-related adverse events, and absence of secondary surgeries at the treated levels,” it says. “Overall success rates at 24 months were 81.4% in the investigational group and 69.4% in the control group. The posterior probability of superiority of the investigation group over the control group was 99.3%.”

Device risks include developing new nerve or spinal cord compression or pain; allergic reactions to implanted material; and bone formation (including heterotopic ossification) that may reduce spinal motion or result in a fusion, either at the treated or at adjacent levels, Medtronic says.