KFx Tissue Fixation Anchor Cleared by FDA

San Diego, Calif.-based KFx Medical Corp. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its 5mm AppianFx Tissue Fixation Anchor. Tissue fixation is a process by which biological tissue it preserved and protected from decay. AppianFx is specifically intended, at least at first, for ankle repair, KFx being a sports medicine company.

“This new anchor enables KFx to expand into the rapidly growing foot and ankle repair and reconstruction market, as well as other applications requiring smaller implants,” said Tate Scott, KFx 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 and ankle surgeons anchors for small-joint procedures.”

Aron Green, M.D., said that the “use of the KFx AppianFx anchor in foot and 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.” Green is a physician at Seaview Orthopedics Ocean in New Jersey.

The AppianFx line of implants from KFx reattach tissue to bone in shoulder, knee, foot and ankle procedures. The implants included in the line include those that directly place and secure tissue into bone both with and without the use of sutures.

KFx Medical Corporation was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine.