Able Medical Devices has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for the use of its Valkyrie RIB System in thoracic repair.
The Valkyrie RIB System is designed for the stabilisation and fixation of fractures in the chest wall, reconstructive surgical procedures, planned osteotomies, and trauma.
The single-use, PEEK device is an extension of Able Medical Devices’ Valkyrie Thoracic Fixation System, which was cleared by the FDA in March 2021.
The system is part of the company’s cardiothoracic and trauma portfolio.
According to the US-based medical device firm, the Valkyrie RIB System adapts to different patient anatomies and lowers patient stress shielding by combining durable fixation with flexibility.
Its cross threading design is said to lessen the possibility of the screw backing out, and the double-lead screws insert into the bone more quickly and with more bone purchase.
Able Medical Devices RAQA and R&D senior director Wade DePas said: “The Valkyrie RIB Thoracic Fixation System creates an adaptive fit to the bone, promoting closer contact with the underlying rib without the need for plate bending tools.
“Supported by material science, this novel system is rooted in clinical history and prioritises adaptability over the conventional norms of rigidity.”
The Valkyrie RIB System is a member of the Valkyrie Thoracic Fixation range.
The Valkyrie system has approval for use in trauma cases, planned osteotomies, and sternal reconstructive surgery cases involving fractures of the chest wall that need to be stabilised and fixed.
Able Medical Devices said that the device is designed to be used in individuals with either normal or low bone quality.
The company is a subsidiary of J.M. Longyear and is engaged in cardiothoracic products production and contract manufacturing.
