Medical device surface technology firm Titan Spine has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Endoskeleton TCS device.
The company has developed interbody fusion device for the cervical spine with integrated fixation.
Titan Spine president Kevin Gemas said: "We are proud to launch the Endoskeleton TCS as the latest addition to our surface engineered interbody device portfolio that continues to challenge the status quo in the interbody fusion marketplace.
"The roughened surface technology featured on the TCS is created through a proprietary process that has been shown to produce a superior environment for bone growth at the cellular level when compared to PEEK."
Seventh interbody device in Titan’s portfolio of titanium spinal implant products, the TCS also uses firm’s surface technology, developed to participate in the fusion process by creating an osteogenic response to the implant’s topography.
The Endoskeleton TCS will be used for integrated fixation with two surface-enhanced screws, which provide for immediate implant mechanical stability.
According to Titan Spine, the screws integrate an anti-backout feature that do not lock the screws to the implant and allow up to 39 degrees of medial-lateral (M/L) and 29 degrees of anterior-posterior (A/P) angulation post-implantation.
Image: Endoskeleton TCS device for cervical fusion with integrated fixation. Photo: courtesy of Business Wire.