Anika Therapeutics receives FDA 510(k) clearance for knotless suture anchor system
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Anika Therapeutics Inc. has announced FDA 510(k) clearance of the X-Twist knotless fixation system for soft tissue repairs in the shoulder, foot and ankle and other extremities, according to a press release.
The X-Twist system is a platform of knotless suture anchors with multiple fixation options for patients undergoing soft tissue repairs, such as rotator cuff repair. According to the release, the system is designed to support cellular infiltration with a double helix thread and multiple sliding suture or tape configurations.
“The clearance of the X-Twist knotless fixation system is another step forward in establishing Anika as a preferred partner within the ASC,” Kevin Stone, vice president and general manager of sports medicine at Anika Therapeutics, said in the release. “Feedback from our surgeon thought leaders has been positive with a specific focus on the versatility of the anchor and the fixation it provides in both soft and hard bone conditions. Surgeons can use the X-Twist in rotator cuff repair for both medial and lateral row applications, as well as other soft tissue procedures where a knotless anchor is desired. This clearance adds to the family of innovative new products to address high opportunity spaces, such as the shoulder market, that will drive accelerated growth for Anika sports medicine and our overall joint preservation portfolio,” Stone said.
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