Navigation Links
FDA Approves First Ceramic-on-Metal Total Hip Replacement System
Date:6/14/2011

SILVER SPRING, Md., June 14, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration approved on June 13 the first ceramic-on-metal total artificial hip system for patients with osteoarthritis.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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 FDA have used different combinations of metal, ceramic, and polyethylene (a form of plastic). 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 postmarket study, monitoring patients receiving the Pinnacle CoMplete system for adverse events and metal ion concentrations in their blood.

DePuy is located in Warsaw, Ind.

For more information:

Hip Implant Systems
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241594.htm

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... ROCKVILLE, Md. , Sept. 22, 2017  As ... by Republican Senators Bill Cassidy (R-LA) and ... Kalorama Information notes that the medical device industry is ... the medical device tax, the 2.3% excise tax on ... Act.  But they also want covered patients, increased visits ...
(Date:9/19/2017)...   ZirMed Inc ., a recognized leader in cloud-based ... has been ranked #1 by its users for the seventh ... User Survey. ZirMed was recognized as the top-ranked end-to-end revenue ... centers over 200 beds and holds one of the longest ... history. ...
(Date:9/13/2017)... 13, 2017   OrthoAtlanta has been named the ... Host Committee (AFHC) for the 2018 College Football Playoff (CFP) ... at Mercedes-Benz Stadium in Atlanta, Georgia . ... "I,m In" campaign, participating in many activities leading up to, ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... As health professionals work to improve their approach to healthcare, there is a ... filling out a survey; in many cases health professionals and patients are working together ... research on the importance of active engagement with patients and members of the public ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate ... primary prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the Mission ... lost souls in the Philippines. “The Journey: From the Mountains to the Mission Field” ... the Bible. She has taught all ages and currently teaches a class of ladies ...
(Date:10/12/2017)... Wis. (PRWEB) , ... October 12, 2017 , ... ... standard products to meet the demand of today’s consumer and regulatory authorities worldwide. ... of probiotic experts and tested to meet the highest standard. , These ...
Breaking Medicine News(10 mins):