Conventus Orthopedics, a medical device manufacturer based in Plymouth, Minnesota, announced that it received approval from the United States Food and Drug Administration for its wrist fracture implant, the Conventus DRS.
According to a press release by the company, the Conventus DRS is designed to replace the volar plate implants traditionally used to correct fractures of the distal radius. The new Conventus DRS only require a small incision on the forearm and a few very small incisions on a patient’s wrist. The fragment-specific system also has similar fix stability compared to traditional screws and plates.
The company also stated that the Conventus DRS is the first FDA-approved device that addresses a wide variety of different fractures. The device will also be able to reduce surgical trauma from an operation by 80 percent compared to traditional techniques. The device can preserve soft tissue around the site of a fracture to minimize pain, swelling and stiffness.
Paul Hindrichs in the CEO of Conventus. In prepared remarks, he said, "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.”
- How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance - Webcast
- 3 Tips for Successfully Launching an Outsourced Medical Device - Webcast
- When Do I Really Need to Perform an Ethylene Oxide Requalification? - Webcast
- Rapid Prototyping for Medical Devices - Webcast
- New Approaches to Assessing Biocompatibility for Medical Devices - Webcast
- Five Mistakes That Can Derail Your Product Development Effort - Webcast