The FDA Has Approved the 1st 3D-Printed Face Bones

Aug 26, 2014

By Eric Hal Schwartz


Hospitals might soon end up with 3D printers next to their X-ray machines now that the FDA has approved a 3D-printed skull bone replacement implant. The implant, technically called the OsteoFab Patient-Specific Facial Device (OPSFD), is basically a specialized hard plastic that is similar to bone, and printed in to finely mimic the facial bone that is missing in shape and function. If your cheek bone were to be shattered beyond normal repair, this implant could help ensure you could soon look and function about as well as you did before. Oxford Performance Materials, which created the implant, was also the first to get FDA approval a similar implant for the cranium, the part of the skull that  is not the face.

“There has been a substantial unmet need in personalized medicine for truly individualized – yet economical – solutions for facial reconstruction, and the FDA’s clearance of OPM’s latest orthopedic implant marks a new era in the standard of care for facial reconstruction,” said Scott DeFelice, OPM’s CEO in a statement. “Until now, a technology did not exist that could treat the highly complex anatomy of these demanding cases. With the clearance of our 3D printed facial device, we now have the ability to treat these extremely complex cases in a highly effective and economical way, printing patient-specific maxillofacial implants from individualized MRI or CT digital image files from the surgeon.”

Continue reading here.

4 comments on “The FDA Has Approved the 1st 3D-Printed Face Bones

  • This is deeply satisfying stuff. I have been teaching 3D modelling and animation for CGI using open source software for some years now and last year convinced my school to purchase a 3D printer, been a steep learning curve (the cheaper machines are not yet very reliable – lots can go wrong). I met a fair bit of resistance from some staff who saw it as me wanting to play with cool toys, I argued that there were likely to be numerous commercial and medical applications in a few years and someone is going to need to know how to design, modify and manipulate 3D models. Nice to see more and more vindication.

    I was showing three year 11 students the 3D printer today, and showed them some fossils I printed from CT scanned I got off the internet of five early homonids I printed for the science department. “Are those of actual fossils?” one girl asked, I said “Well these are copies of actual fossils that have been scanned and I have printed from the scans and they weren’t humans yet. They were pre-human but you can see here the hole where the spinal chord goes out the bottom of the skull not the back where they are in other apes, so these apes walked upright like us” I showed them the large gaps where the stronger jaw muscles pass to the jaw and had them feel their own and explained that they obviously needed to eat harder food than us. She felt the hole where the spinal chord entered. “You can see their brain case was smaller than ours” I added. She then looked up and said “So evolution is true then”. “Well yes all the evidence certainly points that way”. “Well” she said, “I’m not bothering with all that Jesus crap then”. So there you go 3D printing = atheism at least some times.

    Report abuse

  • Hospitals might soon end up with 3D printers next to their X-ray machines now that the FDA has approved a 3D-printed skull bone replacement implant. The implant, technically called the OsteoFab Patient-Specific Facial Device (OPSFD), is basically a specialized hard plastic that is similar to bone, and printed in to finely mimic the facial bone that is missing in shape and function.

    The next step is to put two technologies together and print the patients’ own bone forming cells:-

    More than 100,000 people are waiting for organ transplants in the U.S. alone; every day 18 of them die. Not only are healthy organs in short supply, but donor and patient also have to be closely matched, or the patient’s immune system may reject the transplant. A new kind of solution is incubating in medical labs: “bioartificial” organs grown from the patient’s own cells. Thirty people have received lab-grown bladders already, and other engineered organs are in the pipeline.

    Solid organs with lots of blood vessels, such as kidneys or livers, are harder to grow than hollow ones like bladders. But Atala’s group—which is working on 22 organs and tissues, including ears—recently made a functioning piece of human liver. One tool they use is similar to an ink-jet printer; it “prints” different types of cells and the organ scaffold one layer at a time.

    Report abuse

  • @OP- link – It’s an amazing reminder that 3D printing for manufacturing and industry is taking off in all sorts of ways. It’s gone rapidly from a fun way to make personalized jewelry, to a source for rocket engine parts and more. The materials and process for making the facial implants are an extraordinary level above the simple laying-down of plastic that 3D-printing started with. And as the ability to digitally model objects, including bones, improves, there’s no telling how much 3D printing could do to help people, and for a surprisingly low-cost for what sounds like a very science fiction kind of procedure.

    I put a link to 3D printed rocket engine injectors, on this discussion!

    Report abuse

Leave a Reply

View our comment policy.