Ceterix Orthopaedics has secured 510 (k) clearance from the US Food and Drug Administration (FDA) for new suture cartridge, offering increased flexibility and improved options for surgeons.
Image: Ceterix secures FDA approval for 0 size suture cartridge. Photo: Courtesy of Somkiat Fakmee/FreeDigitalPhotos.net
Ceterix, which is based in Fremont, California, is backed by investors Versant Ventures, 5AM Ventures and CRG.
The clearance is for an added feature to the NovoStitch Pro meniscal repair system – a size 0 suture cartridge, providing surgeons more options to repair meniscal tears.
The NovoStitch Pro system allows surgeons to place stitches arthroscopically in tight joint compartments. It enables them to address meniscal tears that have not been amenable to repair in the past.
The new 0 suture cartridge offers strength and flexibility to support in meniscal repair. It gives surgeons expanded options in suture size and carry out a complete stitch within the knee joint without removing the device for reloading a suture.
Ceterix president and CEO John McCutcheon said: “Ceterix continues to bring advanced technology to orthopaedic surgeons who are looking for better ways to preserve the meniscus. This latest innovation will be especially beneficial to those surgeons who prefer an ‘all-inside, all-suture’ procedure with a stronger suture for the more-demanding meniscal root repairs.”
The meniscus is a crescent of soft cartilage that lies between the femur and tibia, offering stability and shock absorption to the knee. The meniscus attaches to the tibia at its root but is subject to tearing at this attachment point.
In the past, this type of repair would have been treated with meniscectomy (complete or partial removal of the meniscus). Studies have shown that this increases patient’s risk of developing osteoarthritis, which may lead to total knee replacement later in life.
Ceterix reported that over 100,000 patients experience a common yet debilitating type of meniscal injury known as a meniscal root tear, each year. With the availability of the 0 suture cartridge to the NovoStitch Pro system, physicians now have greater flexibility in performing meniscal root and other complex repairs.
The NovoStitch system is indicated for approximation of soft tissue in meniscal repair procedures.