ApiFix Earns FDA Approval for Scoliosis Device
The FDA granted ApiFix a humanitarian device exemption for its MID-C (minimally invasive deformity correction) device for treating progressive adolescent idiopathic scoliosis.
The device treats the most common type of scoliosis with no identifiable cause, which affects two to three percent of children between the ages of ten and 21.
MID-C allows surgeons to perform a procedure that gives permanent curve correction while keeping the flexibility of the spine. The procedure is less invasive than spinal fusion.