Advertisements

First 3D Printed Ti Implant for the Sacroiliac Joint Gets FDA Clearance

Titanium has been used to 3D print all sorts of items, like hearing aids and airplane parts, and even a Garmin cycle mount, but the metal is really making a difference in the medical field. We’ve seen 3D printed titanium vertebrae, spinal interbody devices, and every type of titanium implant you can imagine, from hip implants and jaw implants to a titanium mini-plate implant system used to fix a man’s drooping eye. As we know, it can be a challenge to receive FDA clearance for medical devices and medicine developed with 3D printing technology as 3D printers and medical regulations come into increasing focus. We have so far seen 3D printed titanium cranial/craniofacial implants and a 3D printed titanium digital fusion implant receive the coveted stamp of FDA approval. And today, California-based medical device company SI-BONE announced that it has joined the ranks of the FDA approved.

SI-BONE is dedicated to developing, manufacturing, and commercializing minimally invasive surgical (MIS) devices for patients with low back symptoms, and pioneered the use of its triangular MIS iFuse Implant System, which is used for fusion for certain disorders of the sacroiliac (SI) joint. This joint is between the ilium and sacrum bones on each side of the pelvis; the sacrum supports the spine, and the ilium supports the sacrum.

The company announced today that it has received FDA clearance for its patented iFuse-3D Implant, its next-generation member of the iFuse Implant System and the first 3D printed titanium implant for use in the SI joint. SI-BONE also announced the full commercial launch of the iFuse-3D in the US.

SI-BONE developed a proprietary 3D printing technology in order to develop the implant, which features an enhanced porous surface that resembles the trabeculur structure of cancellous bone and a unique fenestrated design; both of these features combine to make an environment that promotes bone ongrowth, ingrowth, through growth, and intra-articular fusion. It also leverages the triangular design of the iFuse Implant System, which is clinically proven after being used in over 26,000 procedures and supported by more than 50 peer-reviewed publicatons.

By Sarah Saunders | 3DPRINT.COM

Image Credit: SI-BONE

READ MORE

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Materialise Medical Blog

behind the scenes of 3D printing

CB Insights - Blog

Discovering, compiling and sharing orthopedic and medical technology news on a daily basis.

My Knee Your Knee

Knee Replacement Surgery on a Knee Replacement Surgeon

TEDMED Blog

Discovering, compiling and sharing orthopedic and medical technology news on a daily basis.

KevinMD.com

Discovering, compiling and sharing orthopedic and medical technology news on a daily basis.

Page Array – Rock Health

Discovering, compiling and sharing orthopedic and medical technology news on a daily basis.

mobihealthnews

mobihealthnews - the daily mHealth industry monitor. Subscribe for our free weekly e-newsletter!

TechCrunch

Startup and Technology News

Sports Medicine Weekly

Brought to You by Dr. Brian Cole & Steve Kashul

OrthoBuzz

Keeping you up-to-date with orthopaedic news

%d bloggers like this: