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Dallen Medical Gains 510(k) Clearance for Disposable Staple System

July 2, 2014

Orthopedic devicemaker Dallen Medical said Tuesday it has received FDA 510(k) clearance for a disposable version of its Compressyn staple delivery system for small bone fixation, specifically in foot, ankle and hand applications.

The San Clemente, Calif., company said the system meets clinician demand for a more affordable system without diminishing the original system’s superior fixation.

The system delivers constant, dynamic compression through a stainless steel staple that springs into position upon delivery, providing active tension, the devicemaker said. The Compressyn staple is more rigid than a nitinol staple and minimizes the risk of splaying, Dallen notes, which improves patient outcomes — reducing the length of hospital stay and treatment costs.

Dallen’s initial Compressyn staple received 510(k) clearance in February 2013. — Kellen Owings

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