11.16.11
Miamisburg, Ohio-based X-spine, has received clearance from the U.S. Food and Drug Administration for its Calix PC spinal implant system, expanding the firm's portfolio of spinal devices.
The Calix PC is an intervertebral body fusion system consisting of titanium-coated PEEK (polyetheretherketone) spinal implants. X-spine uses a unique plasma coating process to selectively adhere a frictional 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, according to the company.
“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,” sais 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.”
According to Kirschman, the implant demonstrated 79 percent 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,” Kirschman said. “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.”
X-spine is privately-held.
The Calix PC is an intervertebral body fusion system consisting of titanium-coated PEEK (polyetheretherketone) spinal implants. X-spine uses a unique plasma coating process to selectively adhere a frictional 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, according to the company.
“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,” sais 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.”
According to Kirschman, the implant demonstrated 79 percent 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,” Kirschman said. “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.”
X-spine is privately-held.