Three-dimensional (3D) printed orthopedic implants that have a design that is approved or cleared by the Food and Drug Administration (FDA) and produced in standard sizes for patients with typical bone and joint anatomy are investigational.
Patient-matched 3D printed implants that are based on non-standard shapes and sizes for patients with typical bone and joint anatomy and do not qualify as custom devices according to FDA custom device exemption requirements are investigational.
Custom 3D printed implants for patients with bone or joint deformity may be considered medically necessary when the devices are produced at a central manufacturing facility and meet FDA custom device exemption requirements.
Three-dimensional printed orthopedic implants produced outside of FDA-regulated manufacturing facilities are investigational.