Sam Brusco, Associate Editor01.25.24
Able Medical Devices has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Valkyrie RIB system, a single-use, PEEK device indicated for fracture stabilization and fixation in the chest wall, reconstructive surgical procedures, trauma, and planned osteotomies.
The PEEK-based system, according to the company, helps minimize patient stress shielding and conforms to meet various anatomies. Valkyrie RIB’s double-lead screws insert into the bone more quickly, increase bone purchase, and a “zero-chance” cross-threading configuration lowers risk of screw back out.
Wade DePas, Able’s senior director of RAQA and R&D said Valkyrie RIB creates an adaptive fit to the bone, promoting closer contact with the underlying rib without needing plate bending tools. “Supported by material science, this novel system is rooted in clinical history and prioritizes adaptability over the conventional norms of rigidity,” he told the press.
“Ribs can elastically bend more than any other skeletal structure in the body, so offering a material that mimics native bone reduces the risk of stress shielding and offers several additional advantages over traditional metal plates,” added Peter J. Didyk, Able’s VP and managing director of Cardiothoracic and an inventor of the Valkyrie system. “Its minimal instrumentation focuses on speed, efficiency, and simplicity in the O.R. All of this, makes the Valkyrie RIB system a highly desirable product to the market.”
Valkyrie RIB is an extension of the company’s Valkyrie thoracic fixation system, which first launched in 2021.
The PEEK-based system, according to the company, helps minimize patient stress shielding and conforms to meet various anatomies. Valkyrie RIB’s double-lead screws insert into the bone more quickly, increase bone purchase, and a “zero-chance” cross-threading configuration lowers risk of screw back out.
Wade DePas, Able’s senior director of RAQA and R&D said Valkyrie RIB creates an adaptive fit to the bone, promoting closer contact with the underlying rib without needing plate bending tools. “Supported by material science, this novel system is rooted in clinical history and prioritizes adaptability over the conventional norms of rigidity,” he told the press.
“Ribs can elastically bend more than any other skeletal structure in the body, so offering a material that mimics native bone reduces the risk of stress shielding and offers several additional advantages over traditional metal plates,” added Peter J. Didyk, Able’s VP and managing director of Cardiothoracic and an inventor of the Valkyrie system. “Its minimal instrumentation focuses on speed, efficiency, and simplicity in the O.R. All of this, makes the Valkyrie RIB system a highly desirable product to the market.”
Valkyrie RIB is an extension of the company’s Valkyrie thoracic fixation system, which first launched in 2021.