Ceramic Industry News

FDA Approves First Ceramic-on-Metal Total Hip Replacement System

June 24, 2011
/ Print / Reprints /
ShareMore
/ Text Size+

The U.S. Food and Drug Administration (FDA) recently approved the first ceramic-on-metal total artificial hip system for patients with osteoarthritis. Hip joints consist of bone in the shape of a ball at the top of the thighbone (femur) that fits into a rounded socket in the pelvis (acetabulum). During total hip replacement surgery, worn and damaged portions of bone and cartilage are removed and replaced with an artificial hip joint. Specifically, a shell or cup replaces the socket, a stem is inserted into the thighbone and a femoral head or ball at the top of the stem is fitted inside the curved artificial socket where the ball can slide around, allowing for movement.

Previous total hip replacement systems cleared or approved by the FDA have used different combinations of metal, ceramic and polyethylene. The Pinnacle CoMplete Acetabular Hip System is the first to combine a ceramic ball and a metal socket.

“Orthopedic surgeons and their patients now have an additional option for total hip replacement with the approval of the Pinnacle CoMplete Acetabular Hip System,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

The FDA’s approval is based on a two-year randomized clinical trial, which found no clinical difference between 194 patients who received the new ceramic-on-metal system and 196 patients in a control group who received a metal-on-metal hip implant. Two patients who received the Pinnacle CoMplete system required a second surgery to replace their new implant compared with three patients who required a second surgery in the control group.

As a condition of FDA approval, the manufacturer, DePuy Orthopaedics Inc., will conduct a post-market study, monitoring patients receiving the Pinnacle CoMplete system for adverse events and metal ion concentrations in their blood.

For more information, visit www.depuy.com or www.fda.gov.

Did you enjoy this article? Click here to subscribe to Ceramic Industry Magazine.

You must login or register in order to post a comment.

Multimedia

Videos

Image Galleries

June 2014 Issue Highlights

Our June 2014 issue is now available!

Podcasts

Manufacturing Day 2014

Manufacturing Day organizers share their insights with Managing Editor Kelsey Seidler.

More Podcasts

Ceramic Industry Magazine

CI September 2014 cover

2014 September

You won't want to miss the CI Top 10, traditionally our most popular article of the year!

Table Of Contents Subscribe

THE CERAMIC INDUSTRY STORE

M:\General Shared\__AEC Store Katie Z\AEC Store\Images\Ceramics Industry\handbook of advanced ceramics.gif
Handbook of Advanced Ceramics Machining

Ceramics, with their unique properties and diverse applications, hold the potential to revolutionize many industries, including automotive and semiconductors.

More Products

Clear Seas Research

Clear Seas ResearchWith access to over one million professionals and more than 60 industry-specific publications,Clear Seas Research offers relevant insights from those who know your industry best. Let us customize a market research solution that exceeds your marketing goals.

Directories

CI Data Book July 2012

Ceramic Industry's Directories including Components, Equipment Digest, Services, Data Book & Buyers Guide, Materials Handbook and much more!

STAY CONNECTED

facebook_40px twitter_40px  youtube_40pxlinkedin_40google+ icon 40px