Spinal Simplicity, LLC, a medical device company in Overland Park, Kansas, is launching a new generation of its Minuteman G3 fusion device that features an FDA-cleared coating of hydroxyapatite (HA).
“HA, also known as a ‘bone mineral’, has been used in orthopedic procedures for the last 30 years because of its successful track record, ” said Todd Moseley, CEO and co-founder of Spinal Simplicity. He said that the mineral is naturally occurring in human teeth and bones and can be successfully synthesized.
According to officials at Spinal Simplicity, the reason HA coated devices have not been adopted into more procedures is because they had not been packaged into the form of sterile implants.
Jonathan Hess, vice president of business development, explained. “For companies to try to accomplish what we’re doing retrospectively, they’d have to seek new clearances from the FDA. By switching to sterile pack processing they’d have to start over with new inventory, requiring excessive time and money. With Spinal Simplicity integrating a sterile packed implant since its inception, we are able to offer a better solution to our customer surgeons and their patients.”
After Spinal Simplicity’s launching of the Minuteman G3 implant device with HA coating, several industry leading surgeons have worked with the product. Among them are Omar Osmani, M.D., from New Mexico, Elizabeth Trinidad, M.D., from Florida, Larry Khoo, M.D., from California, and Randolph Bishop, M.D., from Georgia. Each physician successfully implanted the HA Minuteman G3 in April and May of this year.
