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FDA grants 510(k) for Dallen's Compressyn staple delivery system

Manufacturing Group | July 15, 2014

Disposable system is designed to respond to clinician demand for a less expensive solution complementing its reusable system.

FDA grants 510(k) for Dallen's Compressyn staple delivery system

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Dallen Medical's disposable version of Compressyn staple delivery system for small bone fixation.

According to company officials, the disposable system is designed to respond to clinician demand for a less expensive solution that complements its reusable system and delivers the same level of fixation.

The Compressyn system includes a stainless steel staple that springs into position upon delivery, providing active tension that creates strong, consistent compression.

More rigid than a nitinol type, the Compressyn staple reduces the risk of splaying and improves patient outcomes.

The staple design also virtually reduced distraction, which has been an issue with competitive stainless steel offerings, according to the company.

It has been designed to respond to clinician demand for a less expensive system that complements its reusable system and delivers the same superior fixation.

This clearance marks the sixth FDA clearance for the company in the last 18 months.

The company's patented Compressyn technology is claimed to be the only rigid compression fixation technology that delivers continual, dynamic compression for small bone fixation.

Dallen Medical chief executive officer David Mills said: "The Compressyn staple is designed to provide surgeons with the highest standard of rigid compression leading to optimal patient outcomes, enabling them to provide the best possible care to their patients."

Recently, the company had filed an application to the FDA for approval of an acromioclavicular (AC) ligament repair device for shoulder separation as part of its Tensyn band product line.

According to the company, Tensyn technology provides proprietary, knotless banding for stabilised fixation of the ankle and other anatomy that does not require rigid compression.

Source: Dadllen Medical

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