Orthopaedic device company 4WEB Medical announced that the US Food and Drug Administration (FDA) has granted 510(k) approval to market its Cervical Spine Truss System-Stand Alone (CSTS-SA) interbody fusion device.
4WEB Medical is engaged in developing advanced medical implants based on its Truss Implant Technology platform. The technology makes use of the mechanobiology concept to simulate cellular activity at the surgical site.
The manufacturing process employed in the production of the implant creates a graded surface roughness that ranges from macro to nano scale.
According to the company, the in-vitro testing of the technology showed that stem cells attached to 4WEB’s titanium implant surface presented improved gene expression of certain osteogenic markers, compared to smooth titanium and PEEK.
4WEB sales and marketing senior vice president Jim Bruty said: “We are thrilled to be able to expand our market leading portfolio in the titanium interbody space. The addition of the Cervical Spine Truss System-Stand Alone product line not only broadens our current portfolio, but represents the first of many products to be released that will provide significant growth for the organization.
“4WEB will continue to provide clinicians with disruptive, clinically beneficial technology achieved through product development.”
CSTS-SA interbody fusion device incorporates 4WEB Medical’s Truss Implant Technology platform
The medical device firm said that similar to its existing product portfolio, it has developed CSTS-SA with an open architecture, and advanced structural design, incorporating its Truss Implant Technology.
Designed to facilitate fixation screws to be placed through the truss implant and into the adjacent vertebral bodies, CSTS-SA creates a zero-profile stand-alone construct that eliminates the need for a traditional plate and screw fixation.
In addition, the device is equipped with a single-step locking mechanism that provides confidence for surgeons to perform the stand-alone construct.
Planned to be launched in the fourth quarter of 2019, the product will be available in multiple footprints, lordotic angles, heights and delivered in sterile packaging for hospital efficiency and patient safety.
