4WEB Medical gets USFDA clearance for cervical stand-alone interbody fusion device

Consistent with 4WEB's existing product portfolio, CSTS-SA has an open architecture, Advanced Structural Design that incorporates the company's proprietary Truss Implant Technology. The CSTS-SA product is designed to allow fixation screws to be placed through the truss implant and into the adjacent vertebral bodies creating a zero-profile stand-alone construct that removes the need for a traditional plate and screw fixation.

Additionally, the device features a single-step locking mechanism that provides surgeon users confidence in the performance of the stand-alone construct. The Cervical Stand-Alone product line will be available in multiple footprints, lordotic angles, heights and will be delivered in sterile packaging for hospital efficiency and patient safety. 4WEB expects to take the product to market at the beginning of the fourth quarter.

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4WEB Medical's proprietary Truss Implant Technology utilizes the concept of mechanobiology to simulate cellular activity at the surgical site. The manufacturing process used to produce the implant's Advanced Structural Design creates a hierarchical surface roughness with features that span from the macro to nano-scale. In-vitro testing has shown that stem cells attached to 4WEB's titanium implant surface exhibited increased gene expression of certain osteogenic markers when compared to smooth titanium and PEEK.