FDA OKs Dallen Medical’s Staple Delivery System for Small-Bone Fixation

San Clemente, Calif.-based Dallen Medical Inc., received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a disposable version of its Compressyn staple delivery system for small-bone fixation. The disposable system is 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.

According to Dallen Medical, its Compressyn technology is the only rigid compression fixation technology that delivers continual, dynamic compression for small-bone fixation.

The Compressyn system features a proprietary, stainless steel staple that springs into position upon delivery, providing active tension that creates strong, consistent compression. The Compressyn staples are more rigid than nitinol staples, minimizing the risk of splaying and improving patient outcomes, which may reduce treatment costs and length of hospital stay. The unique staple design also virtually eliminates distraction, which has been an issue with competitive stainless steel offerings.

“By adding a disposable system to our portfolio, we will be able to offer hospitals and surgery centers a more affordable option for small bone fixation without diminishing the system’s superior results, which responds to current efforts to improve the cost and quality dynamic in the healthcare system,” said Dallen Medical CEO David Mills. “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.”

The company recently filed a FDA submission for an acromioclavicular ligament repair device for shoulder separation as part of its Tensyn band product line. The Tensyn technology is designed to offers knotless banding for stabilized fixation of the ankle and other anatomy that does not require rigid compression.

Dallen Medical is an early-stage orthopedic focused on fixation and compression.