OrthoNovis, Inc. Receives FDA 510(k) Clearance to Market Innovative Wrist Fracture System

PALM COAST, Fla., Feb. 25, 2025 /PRNewswire/ -- OrthoNovis, Inc is proud to announce that it has received U.S. Food and Drug Administration (FDA) clearance to market its innovative BPS Wrist Fracture System. www.orthonovis.com

The 510(k) clearance authorizes OrthoNovis to market a line of locking wrist plates designed for the fixation of certain fractures, fusions, or osteotomies in the distal radius.

"This milestone will allow OrthoNovis to compete in the rapidly growing US orthopedic fracture fixation market," says Ken West, President, and CEO. "Our BPS Wrist Fracture System is a critical step in the build-out of our complete line of orthopedic implants featuring our patented technologies and financially responsible pricing. We are well positioned to grow and will be releasing several new product lines that will address the treatment and fixation of commonly performed Orthopaedic procedures."

About OrthoNovis: OrthoNovis, Inc is a manufacturer and marketer of high quality, best in class Orthopaedic products sold at financially responsible prices. We seek to prove that superior products and lower costs can go hand in hand. OrthoNovis focuses on widely used, market proven products used to treat common fractures and bone osteotomies. The resulting products incorporate patented and clinically advanced features and are priced significantly less than the competition. OrthoNovis customers include ambulatory surgery centers, hospitals, and orthopedic surgeons. Please contact us at [email protected] 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 OrthoNovis such as the statements that OrthoNovis anticipates the launch of the locking plate and screw systems There are numerous risks and uncertainties that could cause actual results and OrthoNovis's plans and objectives to differ materially from those expressed in the forward-looking information. 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, OrthoNovis does not intend to update these forward-looking statements.

SOURCE ORTHONOVIS