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X-spine Announces FDA Clearance of Novel Calix-PC Spinal Implant System.

MIAMISBURG, Ohio -- X-spine, a global manufacturer of devices for the treatment of spinal disease, today announced FDA clearance of the Calix PC[TM] Spinal Implant System to join its growing portfolio of innovative spinal devices. The Calix PC is an intervertebral body fusion system consisting of titanium coated PEEK (Polyetheretherketone) spinal implants. X-spine utilizes a unique plasma coating process to selectively adhere a frictional commercially-pure titanium coating to the bone-apposing surfaces of the device. As a result, the Calix PC demonstrates improved resistance to device expulsion versus a non-coated device in laboratory testing.

"The selective coating of plasma-sprayed titanium to a polymer substrate in an intervertebral implant is potentially the most important development in intervertebral fusion technology since the introduction of PEEK implants a decade ago," states Dr. David Kirschman, President and CEO of X-spine. "The Calix PC provides the benefit of a metallic surface while preserving the desirable qualities of PEEK, namely bone-equivalent modulus and radiolucency."

The Calix PC demonstrated 79% greater resistance to expulsion forces than the equivalent non-coated device in laboratory testing. "Optimal expulsion performance adds an additional safety factor in the critical early postoperative period," continues Dr. Kirschman. "This type of device exemplifies X-spine's commitment to develop devices which add real value to the patient and surgeon. The clearance of the Calix PC represents the culmination of several years of technical hurdles to develop a safe, durable and reproducible process to integrate metallic and non-metallic biomaterials in a high-performance implant system."

The Calix PC system joins X-spine's continually expanding portfolio of innovative spinal devices, including the AXLE[TM] Interspinous Fusion System, the FIXCET[TM] Facet Fixation System, the FORTEX[TM] and X90[TM] Pedicle Screw Systems, the SPIDER[TM] Cervical Plating System, and the HGRAFT[TM] Spinal Allograft System. All X-spine implants are made in the USA.

X-spine ( is a developer and manufacturer of advanced technologies for the treatment of spinal disease. Based in Ohio, the privately-held company manufactures and markets surgical implants and instrumentation worldwide for the treatment of a broad range of spinal pathologies.
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Publication:Business Wire
Geographic Code:1U3OH
Date:Nov 15, 2011
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