MANCHESTER, Conn., March 16, 2023 /PRNewswire/ — Woven Orthopedic Technologies, developer of an implantable sleeve to aid screw fixation in challenging scenarios, announced today that its Ogmend® Implant Enhancement System has received 510(k) clearance from the Food and Drug Administration (FDA) for use in spine surgery.
“We are thrilled to deliver surgeons a simple, reliable solution to help overcome one of the most prevalent yet least discussed challenges in orthopedic and spine surgery: the ability to more confidently use surgical screws when operating in compromised fixation scenarios,” explained Woven Orthopedics’ Co-founder and President, Brandon Bendes.
In orthopedic surgery, surgeons position bones to promote proper healing, and more than a billion screws are implanted each year to securely hold those positions in place during the healing process. However, surgeons routinely face scenarios that make it difficult to achieve secure fixation between screws and bone. In those situations, the Ogmend® Sleeve provides a simple, fast, off-the-shelf solution to hold screws in place. It can be deployed in less than 2 minutes and is used with a wide range of screw systems from a variety of suppliers. It’s very similar to anchors used in construction to secure screws in fragile plaster and drywall.