Orthofix earned FDA 510(k) clearance for its Rodeo telescopic nail, the devicemaker said May 9.
The Rodeo nail is indicated to treat deformities or fractures in patients with osteogenesis imperfecta, according to a news release. It is designed to address biomechanical and procedural challenges associated with OI rod systems and comes with sterilized instrument packs.
The nail will be available in the U.S. in the near future, and has been used in more than 170 clinical cases in Europe.