Amedica Receives FDA Special 510(k) Clearance For Its Valeo(TM) Ceramic Spinal Implant

Main Category: Bones / Orthopaedics
Also Included In: Medical Devices;  Regulatory Affairs / Drug Approvals
Article Date: 12 Dec 2007 - 0:00 PDT

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Amedica Corporation, an orthopedic implants company focused on silicon nitride ceramic technologies, announced that the U.S. Food and Drug Administration has granted a Special 510(k) marketing clearance for Amedica's Valeo(TM) ceramic VBR spinal implant.

The Valeo VBR spinal implant is intended for vertebral body replacement to aid in surgical correction and stabilization of the thoracolumbar spine. The Valeo VBR incorporates Amedica's novel silicon nitride ceramic, which provides new functionalities compared to competing devices currently on the market. The implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spine, even in the absence of fusion, for a prolonged period of time.

"This is an important alternative to spine implants made from titanium and PEEK, as well as bone grafts taken from human cadavers," said Darrel Brodke, M.D., Associate Professor in the Department of Orthopedic Surgery, University of Utah School of Medicine, and Chief of the Spine Service and Medical Director of the University Spine Center. "The ceramic Valeo VBR implants uniquely combine strength with bone apposition, and simultaneously provide the visualization compatibility necessary for medical diagnostic imaging."

"We are very pleased to have received this FDA clearance of our innovative silicon nitride ceramic Valeo VBR implant," said Ashok Khandkar, Ph.D., Chief Executive Officer of Amedica Corporation. "This is an important milestone for Amedica and we remain on track as we progress toward the expected launch of our lead Valeo products in the first half of 2008."

About Amedica

Amedica Corporation is an emerging orthopedic implant company focused on using its silicon nitride ceramic technologies to develop and commercialize a broad range of innovative, high-performance spine and joint implants for the growing orthopedic device market. Its products under development include spine, reconstructive hip and knee implants that may represent a new standard of care in total joint implants based on superior durability, performance and safety.

Amedica Corporation
http://www.amedicacorp.com