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.