FDA clears Calix PC implant system


The US Food and Drug Administration (FDA) has cleared the Calix PC spinal implant system (X-spine).

The Calix PC is an intervertebral body fusion system consisting of titanium coated PEEK (Polyetheretherketone) spinal implants. X-spine utilises 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,” stated 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,” said Kirschman.