Ceterix Orthopaedics Gains FDA Clearance for NovoStitch Pro Meniscal Repair

By Julie A. Vetalice

Ceterix Orthopaedics received FDA 510(k) clearance to market its next-generation 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.

Enhancements to the latest version include an ergonomic and handle, visual cues for stitch placement and improvements to control and stability from upper jaw texturing.

The NovoStitch suture passer hit the U.S. market in 2013, followed by NovoStitch Plus in 2015. At that time, improvements included a pre-loaded suture implant, a design innovation to support ease of use that reduced the number of procedure steps by more than half.

Sources: Ceterix Orthopaedics; ORTHOWORLD Inc.

Product Labels: Traditional Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory