BioArchitects receives approval for additively manufactured titanium cranial implant

February 2, 2016

BioArchitects has announced the 510(k) clearance by the US Food and Drug Administration for the company’s additive manufactured patient specific titanium cranial/craniofacial plate implant. Designed for the repair of defects in the non-loadbearing bones of the head and face, each custom designed plate is permanently attached to the skull and/or face with self-tapping titanium screws.

bioarcitects

This first of its kind in the US, the implant takes advantage of the light weight and high tensile strength properties of the biocompatible titanium alloy and is made using Arcam’s Electron Beam Melting (EBM) technology.

“We are extremely proud to contribute to what we consider another major advance in the trend toward personalised medicine. We believe that this is yet another step toward what will ultimately become the new standard of care,” stated Mark Ulrich, CEO of BioArchitects USA.

Devices of this kind are typically used in the repair of bone defects resulting from trauma, disease, or congenital abnormalities. As each device is specific to the individual, its construction begins with the taking of a CT scan or MRI of the affected area. The scan or image is then imported into a computer design program which is used to create a template of the repair that becomes the model from which the Additive Manufacturing system produces the titanium plate.  

“BioArchitects is a prime example of how innovative organisations are using EBM technology to advance biomedical surgeries that truly effect people’s lives,” stated Magnus Rene, CEO of Arcam Group. “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.”

www.bioarchitects.com 

In the latest issue of Metal AM magazine

Download PDF
 

Extensive AM industry news coverage, as well as the following exclusive deep-dive articles:

  • Revolution, not evolution: General Motors on building an AM culture and the AM Dream Machine
  • The power of Additive Manufacturing in the hands of artists: Public works to small batch production
  • Growing momentum and broadening recognition: A status update on the rise of Electron Beam PBF
  • Improving carbon capture efficiency through Additive Manufacturing in the race for a liveable climate
  • The System of AM Systems: How Metal Powder Works’ in-process powder production could change metal AM
  • The next generation: Using metal AM to drive emissions reduction and educate the engineers of the future
  • Advances in the AM of refractory metals and hard materials at the 20th Plansee Seminar
  • Additive Manufacturing needs you: Why you and your company should get involved in standards development

The world of metal AM to your inbox

Don't miss any new issue of Metal AM magazine, and get the latest industry news. Sign up to our twice weekly newsletter.

Sign up

News from the industry…

    News from the industry…

    Discover our magazine archive…

    The free to access Metal Additive Manufacturing magazine archive offers unparalleled insight into the world of metal Additive Manufacturing from a commercial and technological perspective through:

    • Reports on visits to leading metal AM part manufacturers and industry suppliers
    • Articles on technology and application trends
    • Information on materials developments
    • Reviews of key technical presentations from the international conference circuit
    • International industry news

    All past issues are available to download as free PDFs or view in your browser.

    Browse the archive

    Looking for AM machines, metal powders or part manufacturing services?

    Discover suppliers of these and more in our comprehensive advertisers’ index and buyer’s guide, available in the back of Metal AM magazine.

    • AM machines
    • Process monitoring & calibration
    • Heat treatment & sintering
    • HIP systems & services
    • Pre- & post-processing technology
    • Powders, powder production and analysis
    • Part manufacturers
    • Consulting, training & market data
    Download PDF
    Share via
    Copy link
    Powered by Social Snap