Devices Orthopaedic FDA

 News Release - December 7, 2006

Tornier Receives FDA Clearance for the Salto Talaris(TM) Anatomic Ankle Prosthesis

First U.S. Implantation Performed at Cleveland Clinic

MINNEAPOLIS--(HSMN NewsFeed)--Tornier, a global orthopaedic company and a leader in the market for extremity joint systems, today announced that its Salto Talaris(TM) anatomic ankle prosthesis has been cleared by the United States Food and Drug Administration ("FDA") for commercial use by U.S. physicians. The Salto Talaris(TM) is a newly designed version of the Salto(TM) Ankle Prosthesis, which has been successfully implanted in Europe for the last 9 years.

Doug Kohrs, President and CEO of Tornier commented, "The Salto Talaris(TM) is a next generation ankle replacement that mimics the anatomy and flexion/extension movements of the natural ankle joint. This innovative surgical solution is designed to provide patients with much more mobility than a traditional ankle fusion and more importantly, should also offer patients an improved quality of life."

The Salto Talaris(TM) anatomic ankle is intended for use as a total ankle replacement to relieve pain and significant disability in patients with ankle joints damaged by severe rheumatoid arthritis, post traumatic arthritis, degenerative arthritis, and/or failed previous ankle surgery. The first U.S. implantation of the Salto Talaris(TM) occurred yesterday at Cleveland Clinic. The surgery was performed by Brian Donley, M.D., Vice Chairman of the Department of Orthopaedic Surgery at Cleveland Clinic.

"Joint replacement is in high demand and patients want to remain active after surgery," said Dr. Donley, "We designed this new ankle system with the goal of offering better natural movement and greater comfort with the active patient in mind."

The Salto Talaris(TM) is the latest addition to Tornier's comprehensive orthopaedic extremity implant product line in the United States. This innovative product line includes the Aequalis® cemented, press-fit, and reversed shoulder arthroplasty prostheses, a proximal humeral fracture treatment system as well as a total elbow and radial head arthroplasty prostheses.

For more information regarding Tornier and its novel U.S. product line, visit our website at www.tornier-us.com.

Source: Tornier

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