KFx Medical Corporation has announced it has received FDA 510(k) clearance for its 5mm AppianFx® Tissue Fixation Anchor.
The AppianFx® line of implants from KFx reattach tissue to bone in shoulder, knee, foot and ankle procedures which combined exceed well over 1 million annual surgical procedures. Product offerings include those that directly place and secure tissue into bone both with and without the use of sutures.
The company’s Appianfx in 5mm iteration is size-appropriate for the reattachment of ligamentous structures in foot and ankle surgery. Manufactured from PEEK, the device is non-absorbable and operates in the same way as the company’s other AppianFx implants, hitherto best known for treatment of biceps tenodesis.
“Use of the KFx AppianFx anchor in foot & ankle procedures makes technically challenging cases significantly easier. There is no whip stitching which saves measurable time, and a reliable and reproducible method of tensioning with excellent fixation strength. This device is a game changer,” said Aron Green, MD Seaview Orthopedics Ocean, New Jersey.
Dr. David Abdoo, DPM said, “This anchor is easy to use, less steps and time required for insertion, great pull out strength, and easy ability to adjust tension – Great device.”
“This new anchor enables KFx to expand into the rapidly growing foot & ankle repair and reconstruction market, as well as other applications requiring smaller implants,” remarked Tate Scott, President and CEO. “While the AppianFx® family of implants is successfully being adopted by orthopedic surgeons for a variety of repair and reconstruction procedures in the shoulder and knee, we are excited about offering Foot & Ankle surgeons anchors for small joint procedures and the early customer feedback has been nothing short of remarkable.”
Source: KFx Medical Corporation, Business Wire