Conventus Orthopaedics said the FDA granted 510(k) clearance for its Conventus DRS minimally invasive implant for wrist fractures.
The device is designed to replace traditional volar plate implants used to correct distal radius fractures, requiring a 2-3cm incision on the forearm and "a few tiny incisions at the wrist," according to a press release.
"It represents the 1st minimally-invasive, fragment-specific system that effectively addresses a wide range of fracture types with fixation stability equivalent to traditional plates and screws," according to the release.
"Conventus is very pleased to bring this innovative technology to the U.S., expanding the possibilities for quality patient care. The results from our European clinical study indicate that this will be a very successful technology for distal radius fractures in the U.S. and around the globe. We are enthusiastic about receiving our FDA 510(k) clearance. This supports Conventus’ plans for both U.S. and OUS business expansion," CEO Paul Hindrichs said in prepared remarks.