OrthoNovis Secures FDA Clearance for BPS Wrist Fracture System
26th February, 2025
The 510(k) clearance enables OrthoNovis to enter the U.S. orthopedic fracture fixation market with its innovative locking wrist plates, advancing treatment options for distal radius fractures and fusions.
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.
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."
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