KALAMAZOO, Mich., June 26 /PRNewswire-FirstCall/ -- Stryker Corporation announced today that it has submitted a pre-market approval (PMA) application to the United States Food and Drug Administration (FDA) for the use of OP-1 Putty for posterolateral lumbar spine fusion surgeries.
The product, OP-1 Putty, which contains the recombinant human protein OP-1 that stimulates new bone formation, is currently approved in the United States under a humanitarian device exemption (HDE) for a specific revision spine indication. The HDE approval limits the use of the product in the United States to a patient population of 4,000 per year. A related product, OP-1 Implant for nonunion bone fractures, is approved in 28 countries, including an HDE approval in the United States.
Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. Stryker also provides outpatient physical therapy services in the United States.
CONTACT: Dean H. Bergy, Vice President and Chief Financial Officer ofStryker Corporation, +1-269-385-2600