Can 3D Printing Revolutionize Orthopaedic Devices? (AAOS)
FDA guidance is a first step
3D printing promises to be a revolution in orthopaedic device manufacturing. In 3D printing, parts are built up layer-by-layer by adding to a workpiece using a variety of materials and energy sources. 3D printing is more technically called additive manufacturing (AM) to distinguish it from traditional machining, which “subtracts” material from a solid billet or from a rough part that was cast or forged.
Although AM has been used in nonmedical industries for some time, it is still a relatively new technology, particularly in medical applications, and requires a careful analysis of risk before new products are introduced into clinical use. Currently, most commercial activity in orthopaedics has been for standard-sized implants. However, some applications of 3D printing have also been for patient-specific implants.
Many of these implants are not truly custom, but cover a large range of size parameters cleared by the U.S. Food and Drug Administration (FDA) in a so-called “envelope submission” (a range of sizes and design parameters). A smaller set of applications have been used for 3D printing of tr...
