Ceterix Orthopaedics Gains FDA Clearance of Size 0 Suture Cartridge

By Julie A. Vetalice

Ceterix Orthopaedics announced FDA 510(k) clearance of a size 0 suture cartridge for use with the NovoStitch® Pro Meniscal Repair System.

NovoStitch technology allows surgeons to place stitches arthroscopically in tight joint compartments to treat complex meniscal tears in knees, hips and shoulders, allowing repairs that were not accessible previously. The size 0 suture is particularly suited to the knee, where it allows surgeons to pass a complete stitch without having to remove the device and reload a suture.

NovoStitch Pro is Ceterix's next-generation version of repair technoloy. In 2Q18, the company received FDA clearance for enhancements such as an ergonomic and handle, visual cues for stitch placement and improvements to control and stability from upper jaw texturing.

Source: Ceterix Orthopaedics

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory