FDA Approves The First 3D printed Cranial/Craniofacial Implant In The US

For the first time in the US, a company has received the 510(k) clearance by the U.S. Food and Drug Administration for their 3D printed patient-specific titanium cranial/craniofacial implant. BioArchitects will be designing these medical implants to repair defects in non-load bearing bones for the head and face. Another amazing benefit of BioArchitects implants would be their ability to customize each implant for an individual patient through CT and MRI scans. The titanium plate will be attached to the skull and or face with self-tapping titanium screws.

BioArchitects will make use of the latest 3D printing technology patented by Arcam AB. Using Arcam’s Electron Beam Melting (EBM) 3D printing technology, BioArchitects is able to produce the implant to the exact specifications the particular patient will need. Additive manufacturing is a fantastic option when looking to manufacture these kinds of delicate implants because of the light weight and high tensile strength properties of the biocompatible titanium alloy.

Magnus Rene, CEO of the Arcam Group, stated “BioArchitects is a prime example of how innovative organizations are using EBM technology to advance biomedical surgeries that truly effect people’s lives. Arcam has been a strategic supplier to the orthopedic market for over a decade and tens of thousands of implants are made yearly from our EBM systems. It is clear that both BioArchitects and Arcam are advancing patient care with new technologies that will make a significant difference in the world of medicine for years to come.”( http://bit.ly/1PZKyAK)

EBM is an additive manufacturing process that uses an electron beam to melt and fuse metal powders at high temperatures and at high speeds. The products produced are lightweight, strong, and extremely precise. These are the main reasons why this technology is the go-to choice for manufacturing orthopedic devices and medical implants.

BioArchitects achievement of receiving their 510(k) certification paves the way for more companies to follow their lead. One of additive manufacturing’s most exciting prospects are the applications in the medical manufacturing field ,and now with BioArchitects recent achievement, other medical manufacturers are sure to follow in their footsteps.

“We are extremely proud to contribute to what we consider another major advance in the trend toward personalized medicine.  We believe that this is yet another step toward what will ultimately become the new standard of care”, Mark Ulrich, CEO of BioArchitects USA said. (http://bit.ly/1PY0lJX)

The 3D printed implants will be generally used to repair bony defects that resulted from trauma, disease, or congenital abnormalities. The benefit of being able to use CT scans or MRI of the affected area will allow manufacturers to custom build an implant for a specific patient, increasing the effectiveness of the device. The CT/ MRI scans will be taken and then uploaded to a computer design program rendering the exact 3D model needed for the additive manufacturing process.

The advancements surrounding 3D printing technology not only impact medical manufacturers, every manufacturing sector is starting to see how additive manufacturing can be used for their own processes.

With more companies looking to make use of all the new additive manufacturing options out there, this will help prove that 3D printing end-use products and components are completely achievable.

Interested in 3D printing? For our next podcast, MFG Talk Radio hosts Tim & Lew will be sitting down with Mitch Free, Founder / CEO at CloudDDM and Alan Amling, VP Marketing, UPS Global Logistics and Distribution, at UPS Supply Chain Solutions, whose companies are using 3D printing to drive their business forward. You can find more information on Tuesday’s show click here.






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