Three-Dimensional Printed Orthopedic Implants
Summary
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. 3D printed orthopedic implants with a design approved or cleared by the FDA and produced in standard sizes for patients with typical bone and joint anatomy are considered investigational. Patient-matched 3D printed implants based on non-standard shapes and sizes for patients with typical bone and joint anatomy, and those that do not qualify as custom devices, are considered investigational. 3D printed orthopedic implants produced outside FDA-regulated manufacturing facilities are also considered investigational.
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