4WEB Medical receives 510(k) clearance to market new integrated cervical plate

CSTS integrated plating solution

4WEB Medical has announced that it has received 510(k) clearance to market the newest additions to the company’s implant portfolio—the Cervical Spine Truss System (CSTS) integrated plating solution, and two cervical interbody line extensions, which include implants with 12 degrees of lordosis and an option for a large footprint. That is according to a recent company press release.

“The CSTS integrated plating solution provides an additional standalone treatment option for 4WEB’s surgeon customers,” Jonathan Hires, director of Research and Development at 4WEB, commented. “With two product launches in Q3 and regulatory clearance for the integrated plate, we have built significant momentum towards completing the company’s comprehensive cervical portfolio by the end of the year.”

4WEB develops innovative orthopaedic implants by leveraging its proprietary Truss Implant Technology. It also claims to have been the first company to receive 510(k) clearance from the US Food and Drug Administration (FDA) for an implant manufactured with 3D-printing technology.

The CSTS integrated plating solution clearance follows several recent milestones including the launch of a non-integrated cervical plating solution and a second-generation cervical interbody fusion device, which came to market in Q3, 4WEB further claims in a press release. Additionally, the company previously announced plans to launch an integrated anchor fixation system in early Q4. This expanded suite of products will provide a variety of cervical fusion constructs for varying anatomical needs, the release also notes.

“The launch of the CSTS integrated plating solution builds on an already robust product portfolio,” said Geoff Bigos, vice president of 4WEB’s Spine Division. “We are excited to launch several new cervical products before the end of the year and look forward to capitalising on this success with significant growth in 2024.”


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