FDA clears Woven Orthopedic Technologies surgical screw enhancer

Woven Orthopedic Technologies announced recently that the FDA granted 510(k) clearance for its Ogmend implant enhancement system.

Manchester, Connecticut-based Woven Orthopedics designed Ogmend for spine surgery. The implantable sleeve aids screw fixation in challenging scenarios.

“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,” said Woven Orthopedics co-founder and President Brandon Bendes.

Ogmend provides a simple, fast, off-the-shelf option to hold screws in place. Deployment takes less than two minutes with a wide range of screw systems from a variety of suppliers. Woven Orthopedics said it’s similar to anchors used in construction to secure screws in fragile plaster and drywall.

The system holds CE mark and recently surpassed the 2,500-unit milestone in Europe. Woven Orthopedics plans to make Ogmend available in the U.S. through a staged, regional release.

“This is game-changing,” said Dr. Frank Cammisa, Jr., chief emeritus of spine at the Hospital for Special Surgery. “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. My colleagues and I are looking forward to having this available in the U.S.”

Original Article:(https://www.massdevice.com/fda-clears-woven-orthopedic-technologies-surgical-screw-enhancer/)