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AAOS Now

Published 9/1/2007

FDA approves Cormet Hip Resurfacing System

The U.S. Food and Drug Administration (FDA) in July approved the Cormet Hip Resurfasing System. As a result, Stryker Corporation has announced that it will begin marketing the system as early as the third quarter of this year. Stryker’s Orthopaedics division previously secured an exclusive 10-year agreement to market and distribute the Cormet Hip Resurfacing System in the United States.

Corin is the first manufacturer to receive FDA approval based on a U.S. prospective, multi-center, clinical study that highlights the importance of appropriate patient selection and surgeon education for this emerging technology segment. The results support the need for surgeons to focus on several key anatomic and physiologic factors when determining if resurfacing is the right option for a patient.

For more information about Stryker, please visit the company web site at www.stryker.com.

FDA approves artificial cervical disk
The U.S. Food and Drug Administration (FDA) has approved the Prestige Cervical Disc, made by Medtronic Sofamor Danek of Memphis, for marketing. The device is the first artificial cervical (neck) disk to be approved for the treatment of cervical degenerative disc disease, one of the most common causes of neck and arm pain.

The Prestige Cervical Disc consists of two main pieces of stainless steel that articulate against one another with a ball and trough (groove). After a doctor removes the impaired natural disk, the artificial disk is attached to the adjacent vertebrae with bone screws.

The FDA based approval on the company’s laboratory and animal testing, and on its clinical study of 541 patients. The approval decision also took into account the recommendations of the Orthopedic and Rehabilitation Devices Panel of FDA’s Medical Devices Advisory Committee.

The Prestige Cervical Disc was approved as a class III device under the pre-market approval process. As a condition of approval, the company will conduct a post-approval study over the next seven years to evaluate the longer term safety and effectiveness of the device.