Ceterix Orthopaedics said today it won FDA clearance for its next-gen NovoStitch Pro meniscal repair system.
The Fremont, Calif.-based company said the newly cleared device is designed to allow surgeons to place stitches arthroscopically in tight joint compartments to treat meniscal tears that had previously been unrepairable.
“This FDA clearance is another important milestone in our mission to reduce the number of meniscectomies and to save the meniscus. Ceterix continues to be the leader in meniscal repair by providing innovations that preserve tissue and sustain the natural biomechanics of the knee joint,” Ceterix prez & CEO John McCutcheon said in a prepared statement.
The NovoStitch device was designed to be easier to use with well-defined visual cues for stitch placement and improved control and stability from upper jaw texturing, Ceterix claims.
“The new NovoStitch Pro meniscal repair system represents a significant improvement to one of the most innovative technologies developed for arthroscopic knee repair. The technological enhancements incorporated into the new system offer the potential to repair tear types that were previously considered difficult or impossible to sew, with improved control and access for the surgeon. I look forward to incorporating it into my practice,” Dr. Peter Kurzweil of Long Beach, Calif.’s Memorial Orthopaedic Surgical Group said in a press release.