Internal Fixation Systems Receives FDA 510(k) Clearance to Market Fixation Devices to Treat Bone Fractures and Osteotomies
9/15/2011 10:50:46 AM
MIAMI, Sept. 14, 2011 /PRNewswire/ -- Internal Fixation Systems, Inc. (OTC QB: IFIX) today announces that it has received U.S. Food and Drug Administration (FDA) clearance to market its bone fixation devices that include various plates, screws, and washers used to treat bone fractures and osteotomies.
The 510(k) clearance authorizes IFS to market a line of locking plates which includes mini-fragment, small fragment, and large fragment systems. The initial system, a modular locking small fragment set, should be available for sale during the 4th quarter 2011.
"The comprehensive family of locking plate products will allow us to compete in the rapidly growing US orthopedic fracture fixation market," says Ken West, Founder and Vice President of Sales. "IFS's enhanced products and responsible pricing should position the company well in this competitive market."
"The locking small fragment system is the first step in the build-out of our complete line of orthopedic implants," according to Christopher D. Endara, Founder and Vice President of Engineering, Operations, Quality, and Regulatory Affairs.
"The approval of these devices will benefit patients and surgeons by providing high quality, cost effective alternatives critical in today's healthcare environment," said Internal Fixation Systems President and CEO, Stephen Dresnick, MD. Over the last 18 months, we have developed several new product lines and are developing the infrastructure to grow."
About IFS: Internal Fixation Systems, Inc is a manufacturer and marketer of high quality, responsibly priced orthopedic and podiatric implants. We seek to prove that superior products and lower costs can go hand in hand. IFS focuses on widely used, market proven products used to treat common fractures. Our Advisory Panel, consisting of nationally recognized surgeons, provides input on how to improve our implant designs. The resulting products incorporate doctor requested enhancements and are priced at 40-60% less than the competition. IFS customers include ambulatory surgery centers, hospitals and orthopedic surgeons. Please contact us for more information about our product and business model.
This press release contains projections and forward-looking information that involve various risks and uncertainties regarding future events. Such forward-looking information can include without limitation statements based on current expectations involving a number of risks and uncertainties and are not guarantees of future performance of Internal Fixation, such as the statements that Internal Fixation anticipates the launch of the locking plate and screw systems There are numerous risks and uncertainties that could cause actual results and Internal Fixation's plans and objectives to differ materially from those expressed in the forward-looking information, including whether Internal Fixation will have sufficient capital to continue its operations.. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and views of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, IFS does not intend to update these forward-looking statements.
SOURCE Internal Fixation Systems, Inc.