ThomasNet News Logo
Sign Up | Log In | ThomasNet Home | Promote Your Business

Proposed ASTM Standard addresses explanted hip implants.

Print | 
Email |  Comment   Share  
December 4, 2013 - To addresses collection and analysis of explanted hip implants, Subcommittee F04.22 on Arthroplasty has developed ASTM WK43442, Guide for the Characterization of Material Loss from Conical Taper Junction Between Femoral Head and Stem in Retrieved Modular Hip Prostheses. Once approved, proposed standard will give user series of options and increase awareness of information and approaches to researchers and companies that need to measure material loss from taper joints in orthopedic devices.

Proposed New ASTM Standard to Provide Guide for Collection and Analysis of Explanted Hip Implants

ASTM International
100 Barr Harbor Dr., Box C700
West Conshohocken, PA, 19428-2959

Press release date: December 2, 2013

W. CONSHOHOCKEN, Pa., —An ASTM International symposium on metal-on-metal total hip replacement devices held in May 2012 identified unmet standardization needs. One such need was for a standard that deals with the collection and analysis of explanted hip implants in order to understand their in-vivo performance. In addition, the U.S. Food and Drug Administration Order 522 mandates orthopaedic companies to carry out retrieval analysis on all explanted metal-on-metal hip components. In response, a proposed new ASTM standard will provide a guide for the industry to follow covering the issue of material loss.

ASTM WK43442, Guide for the Characterization of Material Loss from Conical Taper Junction Between Femoral Head and Stem in Retrieved Modular Hip Prostheses, is being developed bySubcommittee F04.22 on Arthroplasty, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

Once approved, the proposed standard will give the user a series of options and increase awareness of information and approaches to researchers and companies that need to measure the material loss from taper joints in orthopaedic devices.

“In order to understand the in-vivo performance of hip joints, and to understand the mechanisms that lead to material loss, it is essential to be able to accurately and repeatedly measure the material loss from the components,” says Richard Underwood, associate, biomedical engineering practice, Exponent, and a member of F04.22. “This proposed standard will help researchers understand the in-vivo behavior of orthopaedic devices and ultimately design longer-lasting devices.”

Research laboratories and implant manufacturers will be the primary users of ASTM WK43442. Manufacturers are mandated by the U.S. Food and Drug Administration to analyze explanted hip components, and the proposed guide will be used as part of the FDA submission process.

All interested parties are invited to join in the standards developing activities of F04.22. The task group working on ASTM WK43442, F04.22.29 on Metal-on-Metal Clinical Characterization, is also working on the following proposed standards:

• ASTM WK34551, Guide for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices Using Magnetic Resonance Imaging;
• ASTM WK35939, Guide for the Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal Hip Prostheses; and
• ASTM WK38566, Test Method for Measuring Metal Ions in Retrieved Fluid Samples from Total Joint Arthroplasty.

ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit

ASTM International is one of the largest international standards development and delivery systems in the world. ASTM International meets the World Trade Organization (WTO) principles for the development of international standards: coherence, consensus, development dimension, effectiveness, impartiality, openness, relevance and transparency. ASTM standards are accepted and used in research and development, product testing, quality systems and commercial transactions.

For more news in this sector, visit or follow us on Twitter @ASTMMedical.

ASTM Committee F04 Next Meeting: May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada
Technical Contact: Richard Underwood, Ph.D., Exponent, Philadelphia, Pa., Phone: 215-594-8800, ext. 8875;  
ASTM Staff Contact: Pat Picariello, Phone: 610-832-9720;
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603;   
Print | 
Email |  Comment   Share  
Contacts: View detailed contact information.


Post a comment about this story

(your e-mail address will not be posted)
Comment title:
To submit comment, enter the security code shown below and press 'Post Comment'.

 See related product stories
More .....
 See more product news in:
 More New Product News from this company:
ASTM Workshop to address additives in biomedical polymers.
Oil Training Course examines sampling, testing, evaluation.
Radiant Barrier Systems Standards approved by ASTM committee.
Training Course addresses hazards in oxygen systems.
More ....
| Featured Manufacturing Jobs
 Other News from this company:
ASTM/NIBS Workshop on Building Science Education in North America
Fatigue and Fracture of Metallic Medical Materials and Devices
ASTM International Compilation on Silica and Associated Respirable Mineral Particles
Guidance for Potential Solar Photovoltaic Investors to Be Provided in Proposed ASTM Standard
Test for Sustained Air Performance of Central Vacuum Cleaning Units Approved as ASTM Standard
More ....
 Tools for you
Watch Company 
View Company Profile
Company web site
More news from this company
E-mail this story to a friend
Save Story
Search for suppliers of
Trade Associations

Home  |  My ThomasNet News®  |  Industry Market Trends®  |  Submit Release  |  Advertise  |  Contact News  |  About Us
Brought to you by        Browse ThomasNet Directory

Copyright © 2014 Thomas Publishing Company. All Rights Reserved.
Terms of Use - Privacy Policy

Error close

Please enter a valid email address