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Ceterix gets FDA 510(k) approval for NovoStitch Plus meniscal repair system

Ceterix Orthopaedics has received 510(k) approval from the US Food and Drug Administration for its NovoStitch Plus meniscal repair system.

NovoStitch Plus system helps in the placement of a circumferential compression stitch around the meniscus, offering uniform compression during healing and allowing orthopaedic surgeons to treat complex injuries.

The new system enables orthopaedic surgeons to easily address horizontal, radial, and other complex meniscal tears.

NovoStitch Plus device integrates a pre-loaded suture implant, a design innovation that improves ease of use and reduces the number of procedure steps by more than half.

Ceterix Orthopaedics president and CEO John McCutcheon said: "We are very pleased to release this important new technology.

"We believe that the usability improvements in this new device will enable surgeons to provide meniscus repair to an even broader set of patients who need better solutions for this very common knee injury."

Earlier this year, the firm revealed the results of several studies related to NovoStitch, which showed that the sutures delivered with NovoStitch met the strength of those delivered through the gold standard open-surgical approach for two common types of meniscus tears.

The company develops surgical tools to treat soft tissue injuries such as meniscus tears, hip and shoulder labrum tears, and rotator cuff tears.