FDA Clears New Fracture Fixation Cage from Coventus

Minneapolis, Minn.-based Coventus Orthopaedics Inc. has earned 510(k) clearance from the U.S. Food and Drug Administration for its Coventus Cage PR (proximal radius) system. The system is for fractures of the radial head and neck. It is indicated for treatment of proximal radial fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.

This clearance helps Conventus achieve its goal of providing solutions for fracture fixation throughout the body based on a self-expanding scaffold.

Utilizing the shape memory properties of nitinol, the Conventus Cage expands within the bone creating robust, stable fixation and thus prevents collapse of the fracture repair, the company claims. Similar to the company’s first two products, the Conventus Cage DR and Conventus Cage PH, the PR cage creates a rigid substrate designed to self-expand within the bone to avoid interference with soft tissues and ultimately improve upon pronation and supination. Its self-expanding scaffold provides options to achieve, it is hoped, reliable repairs with fewer compromises in peri-articular fractures. The implant is designed to address limitations of conventional approaches to radial head and neck repairs while allowing for preservation of the bony anatomy and preserving future treatment options.

“The approval of this additional indication reflects our commitment to provide more innovative solutions and options for surgeons working to repair orthopedic fractures throughout the body,” said Paul Buckman, Conventus president and CEO. “Our overall goal is to provide a complete platform technology enabling surgeons to treat all trauma and fracture repairs from a 3-dimensional approach.”

Conventus designed and developed the proprietary device in close consultation with an expert group of surgeon advisors. The design is aligned with the principles of the Conventus 3-dimensional Cage platform technology, which emphasize preservation of tissues and blood supply at the fracture site, creating a strong foundation by stabilizing bone fragments and facilitating early motion through less invasive procedures.

Coventus is focused on making less invasive solutions for a range range of peri-articular fractures.