SAN DIEGO--(BUSINESS WIRE)--KFx Medical Corporation announced it has received 510K clearance from the Food and Drug Administration (FDA) for its 5mm AppianFx® Tissue Fixation Anchor.
“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.”
“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 offered his thoughts, "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."
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.
About KFx Medical Corporation
Headquartered in Carlsbad, Calif., 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. The company is privately held — Investors include Alloy Ventures, Charter Life Sciences , Arboretum Ventures, Montreux Equity Partners, and MB Venture Partners.