Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)
The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.
• Adolescent Idiopathic Scoliosis classified as Lenke Type 1 or Type 5 curves;
• Cobb angle between 35-60 degrees (inclusive);
• Flexible curve that that reduces to ≤ 30 degrees on lateral side-bending radiographs or as evident by traction x-ray;
• Kyphosis angles of ≤ 55 degrees measured from T5 to T12;
• Appropriate candidate for posterior surgical approach;
• Patient has good general health;
• Patient has no known hypersensitivity or allergies to titanium;
• Patient's guardian signs a written informed consent form (ICF).