FDA Grants 510(k) Clearance to Ceterix Orthopaedics for Meniscal Repair System
The FDA has granted 510(k) clearance to Ceterix Orthopaedics for its NovoStitch Plus meniscal repair system.
The device enables orthopedic surgeons to address horizontal, radia and other complex meniscal tears in ways not previously possible, the Menlo Park, Calif.-based company says.
Surgeons can place a circumferential compression stitch around the meniscus, providing uniform compression during healing. According to Ceterix, the system incorporates a pre-loaded suture implant, which simplifies the procedure and cuts the number of steps in half.
A health economics study found that meniscus repair can result in cost savings over a total or partial removal of the meniscus, because of the reduced risk of developing osteoarthritis or needing a total knee replacement. — Michael Cipriano