Medical Device Network

FDA grants 510(k) clearance to Able Medical’s thoracic repair system

The Valkyrie RIB system, made from PEEK, is designed to securely hold bones together whilst still offering some flexibility.

The US Food and Drug Administration (FDA) has greenlighted Able Medical’s Valkyrie RIB system, granting 510(k) clearance for the single-use device.

The device is an extension of Able’s Valkyrie thoracic fixation system, used to stabilise and fix fractures in the chest such as in sternal reconstructive surgical procedures, planned osteotomies and trauma fractures to the chest wall.

The device is made from a material called polyether ether ketone (PEEK), a semicrystalline thermoplastic with mechanical and chemical resistance properties. It is designed to hold bones together securely whilst still allowing some flexibility. The screws used in the system are designed to be inserted into the bone quickly and securely.

In the announcement accompanying the approval, senior director of Able’s regulatory affairs and quality assurance (RAQA) 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.”

According to a GlobalData market model, the surgical sutures market will be worth $520.12m by 2030 in the US, increasing at a compound annual growth rate (CAGR) of 2.5% from $414.72m in 2021.

The Michigan-headquartered company develops, manufactures, and sells instruments and implants for orthopaedic, dental, and cardiothoracic original equipment manufacturers (OEMs) partners.

Able, a subsidiary of J.M. Longyear, introduced its stainless-steel Valkyrie Looped Sternotomy Sutures in January last year, used in conjunction with the thoracic fixation system. The sutures are designed for closing a patient’s chest after open-heart surgery, stabilising, and fixing chest wall fractures.

In December 2022, device manufacturer Stryker launched its Citrefix suture anchor system for foot and ankle surgical procedures, featuring Citregen biomaterial.

Zimmer Biomet acquired Vance Street Capital’s portfolio company, A&E Medical, for a total of $250m in 2020, a company which manufactures sternal closure devices. Under the terms of the deal, Zimmer acquired A&E’s sternal closure device portfolio including sternal sutures, cable systems, rigid fixation, and temporary pacing wire and surgical punch products.