4WEB Medical gets USFDA clearance for cervical stand-alone interbody fusion device
New Delhi: 4WEB Medical, an orthopaedic device company focused on developing implants utilizing its proprietary Truss Implant Technology, announced recently that the company has received 510(k) clearance from the U.S. Food and Drug Administration (USFDA) to market its Cervical Spine Truss System-Stand Alone (CSTS-SA) 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.
Commenting on the approval, Jim Bruty, Sr. Vice President of Sales and Marketing 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, " Jim added.
The company remains focused on accelerating growth over the next 5 years with investments in product development, procedural based solutions and clinical research.