CF/PEEK artificial bone cleared for sale, use in U.S.

Switzerland-based icotec has developed a CF/PEEK lumbar spacer that's been approved by the U.S. FDA for sale and distribution in the U.S. The company also received CE approval for its CF/PEEK pedicle screw system.

Related Topics:

icotec (Alstätten, Switzerland) reported on Aug. 5 that is has received U.S. Federal Drug Administration (FDA) clearance for its continuous CF/PEEK Lumbar Spacer ETurn for commercial sale and distribution in the U.S.; CE approval also was given for its pedicle screw system with CF/PEEK rods.

The ETurn lumbar spacer is used as an intervertebral body fusion device (IBF) for posterior intersomatic spondylodesis (PLIF, TLIF and EPLIF). The ETurn Lumbar Spacer is a lumbar fusion device manufactuerd from continuous carbon fiber-reinforced PEEK (CF/PEEK).
The spacer was developed with Professor Fritz Magerl, who says, “The ETurn Lumbar Spacer has a unique guiding surface. Surgeons using this implant are very much in favor of the self- positioning features of the implant. These features improve the surgical technique and may reduce risk of failures.”

The icotec pedicle screw system combines traditional polyaxial titanium alloy screws with carbon fiber-reinforced PEEK (CF/PEEK) rods. Using the CF/PEEK rods, the pedicle screw system shows better mechanical fatigue properties than titanium rods with the same diameter. At the same time, the CF/PEEK rod system is less rigid. The fully radiolucent CF/PEEK rods allow for optimal visualization in imaging procedures.

The company says introduction of the system with CF/PEEK rods is the first step towards introducing a fully composite pedicle screw system. Screw shaft and tulip development are ongoing.