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Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip


Smith & Nephews' Orthopaedics division (NYSE: SNN, LSE: SN) today announced the US Food and Drug Administration's approval of its newest advanced bearing product for patients who undergo total hip replacement surgery, the ceramic-on-ceramic hip. Smith & Nephew will immediately launch the product as an extension of its Reflection family of hip implants.

The approval and introduction of the ceramic-on-ceramic product complements the company's existing line of advanced bearing products for hip replacement surgery, including a hip product made of oxidized zirconium metal, branded OXINIUM◊. Advanced bearing materials are longer wearing and are increasingly used by orthopaedic surgeons to treat younger or more active patients.

"Smith & Nephew Orthopaedics strategy is to become the only orthopaedic company which offers a full range of advanced bearing products for both hips and knees, bringing real choice to surgeons and patients in the United States," said Orthopaedics President, David Illingworth. "With OXINIUM◊, ceramic-on-ceramic, and our metal-on-metal hip product which is already available outside the US, we are leading the way in technological innovation in the hip segment."

The Reflection Ceramic Acetabular System was approved by the FDA as a Pre-Market Approval (PMA) process using the company's own clinical data. The ceramic components will be manufactured for Smith & Nephew by Ceramtec.

"Smith & Nephew's Reflection Cup system has innovated in the hip market for nearly ten years. The introduction of the ceramic bearings in the Reflection system now offers market leading performance in both range of motion and the avoidance of impingement," said Steve Hirsch, Senior Vice President and General Manager of the Reconstructive Division.

Hip replacement devices are designed to replace and replicate the function of a ball-and-socket hip joint. Patients requiring hip replacement surgery have usually been afflicted with either osteoarthritis or some form of degenerative joint disease. In the U.S., surgeons perform nearly 350,000 hip replacements a year.


About Smith & Nephew, Inc.

Smith & Nephew (NYSE: SNN, LSE: SN) is a global medical technology business, specializing in Endoscopy, Orthopaedics and Advanced Wound Management products. Smith & Nephew ranks as the global leader in arthroscopy and one of the world's leaders in advanced wound management and is one of the fastest growing orthopaedics companies in the world.

Smith & Nephew is dedicated to helping improve people's lives. The company prides itself on the strength of its relationships with its surgeon and professional healthcare customers, with whom its name is synonymous with the highest standards of performance, innovation and trust. The company has more than 8,000 employees and operates in 32 countries around the world and generated sales of nearly $2 billion.


Forward-Looking Statements

This press release contains forward-looking statements. The company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, the company's overall business strategy and other factors.


Contact

Victor Rocha
Smith & Nephew, Inc.
Director, Media Relations
(901) 399-6771
victor.rocha@smith-nephew.com