Overview:
FDA has granted 510(k) clearance to a bone fracture fixation system with locking wrist plates.
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a bone fracture fixation system with locking wrist plates.
The wrist fracture system is “indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults.” Notably, it is “indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.”
According to the 510(k) summary document, the system “includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius.” The system is designed to meet different anatomical needs and offers “several sizes of distal radius plates as well as various styles and sizes of locking, nonlocking, and cortical bone screws.” Additionally, the plates are manufactured from “Commercially Pure Titanium Grade 4 per ASTM F67.” The system’s screws are manufactured from “Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136.”
In order to qualify for shorter and earlier 510(k) clearance, a device must be substantially equivalent to a predicate device. Here, per the 510(k) summary document, the technological characteristics are “nearly identical.”
The list of primary and additional predicate devices includes the following: 510(k) number K191641, AFFINITY Variable Angle Distal Radius System; 510(k) number K233919, VariAx 2 Distal Radius System; and 510(k) number K083694, 2.4mm VA-LCP Volar Distal Radius System.
OrthoNovis, Inc. submitted the system for 510(k) clearance. Its trade name is BPS Wrist Fracture System.
OrthoNovis President and CEO Ken West commented, “This milestone will allow OrthoNovis to compete in the rapidly growing U.S. orthopedic fracture fixation market.”
West continued, “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.”
