Ceterix Orthopaedics said yesterday it won expanded FDA 510(k) clearance for its NovoStitch Pro meniscal repair system, clearing the system for use with a size 0 suture cartridge.
The Fremont, Calif.-based company’s NovoStitch Pro system is designed to allow surgeons to place stitches arthroscopically in tight joint compartments to treat meniscal tears that had previously been unrepairable.
“The considerable strain placed on the knee’s meniscus during common physical activities makes it particularly prone to injury. Having access to a larger suture provides additional possibilities for meniscal repair,” Dr. David Flanigan of the Ohio State University Wexner Medical Center said in a prepared statement.
The additional clearance of the new 0 suture cartridge gives surgeons extra options in suture size that can allow them to pass a complete stitch within the knee joint without having to remove the device to reload a suture, Ceterix 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,” prez & CEO John McCutcheon said in a press release.
In April, Ceterix Orthopaedics said that it won FDA clearance for its next-gen NovoStitch Pro meniscal repair system.