Medical technology3 min read
3D printing of medical devices
3D
3D printing builds a three-dimensional object from successive layers of raw material. Commercially available 3D-printed medical devices include orthopaedic and cranial implants, surgical instruments, dental crowns, external prosthetics and devices matched to a patient’s anatomy.
The FDA regulates 3D-printed medical devices through the same pathways it uses for conventional devices. Their notable advantage is the ability to make devices matched to an individual patient's anatomy.
Scientists are investigating the use of 3D printing to make living organs such as the heart or liver, but this research is at an early stage; see Bioprinted organs.
- In widespread clinical use
- Approved for specific uses
- In clinical trials
- Preclinical
- Concept
Commercially available printed devices are regulated by the FDA through the usual device pathways; printing living organs is at the start of research.
- Implants, instruments, crowns and external prosthesesApproved for specific uses
These include bone and skull implants, dental crowns and artificial limbs.1
- Bioprinted living organsPreclinical
Research is at an early stage.2
Status last checked: · What the maturity levels mean
What is it?
3D printing is a type of "additive manufacturing" that makes a three-dimensional object by building up successive layers of raw material.
How does it work?
It allows manufacturers to make devices matched to the patient's anatomy, and the FDA regulates them through the same pathways it uses for conventional devices.
Where is it used today?
Devices produced with it include implants for bone and the skull, surgical instruments, dental crowns and external artificial limbs.
Examples include implants such as skull plates and hip joints.
Limits and risks
Printing living organs such as the heart or liver is still at an early research stage.
Common questions
Is a 3D-printed implant less safe than a conventional one?
The sources do not say so; the FDA regulates printed devices through the same pathways it uses for conventional devices, and any implant is decided on by the specialist doctor.2
Questions for your doctor
- Is the implant proposed for me designed to match my anatomy, and what is its advantage in my case?
References
- 1U.S. FDA. 3D Printing of Medical Devices. www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devicesHealth agencies & guidelines · Accessed 2026-10-08
- 2U.S. FDA. Medical Applications of 3D Printing. www.fda.gov/medical-devices/3d-printing-medical-devices/medical-applications-3d-printingHealth agencies & guidelines · Accessed 2026-10-08
Review status: Edited content · Last updated:
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Educational content only — no diagnosis, and no substitute for a clinician.