A medical technology company, Manchester-based Woven Orthopedic Technologies, has received approval from the Food and Drug Administration for an advancement in orthopedic spine surgery.
Woven Orthopedic has developed an implantable sleeve to aid with screw fixation, called Ogmend Implant Enhancement System.
The company announced it received FDA clearance of its premarket submission, known as a 510(K), demonstrating that the device is safe and effective.
In orthopedic surgery, surgeons position bones to promote proper healing. Surgeons often face scenarios that make it difficult to achieve secure fixation between screws and bone, the company said.
Ogmend provides a solution to hold screws in place that can be deployed in less than two minutes, according to the company.
“This is game changing,” said Dr. Frank Cammisa, Jr., chief emeritus of Spine at the Hospital for Special Surgery, according to a news release. “A large, growing percentage of my patients have conditions that make it difficult to achieve strong fixation. Ogmend gives me a very simple way to manage these patients and generate the fixation needed to ensure great outcomes.”
The concept for Ogmend was invented by Dr. Alexander Jones, a long-serving orthopedic and spine surgeon in the U.S. Navy and Kaiser Permanente Health System.
Ogmend will be made available in the U.S. through a staged, regional release.