Avi Kumar, MD, an orthopedic surgeon with Bradenton, Fla.-based Coastal Orthopedics, performed the first case with a shoulder fracture plate that he invented.
Dr. Kumar came up with the idea for netBiologics Gaudi plate about 20 years ago, according to a March 11 news release shared with Becker’s. The proximal humerus plate addressed an issue with other devices that were too stiff and could delay fracture healing.
Dr. Kumar treated the first patient with the new plate in December, and he’s used the device in three other cases.
“We performed three years of testing and retesting before we submitted our results to the FDA,” Dr. Kumar said in the release. “After submitting our results, the FDA recommended additional testing on the plate and screws, extending the process to four years, but they were very helpful throughout. On our second filing, the FDA accepted our results and cleared the medical device for marketing in the U.S. in July 2024.”
