Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Total disc replacement could have a problem: Here’s why

March 28, 2017 By Heather Thompson

Total disc replacement (TDR) has the potential to replace fusion as the gold standard for treatment of painful degenerative disc disease. However, complications after TDR have been associated with wear and tear, including accelerated polyethylene wear.

total disc replacement

Image courtesy of Blausen staff (2014) under Creative Commons license 3.0.

Retrieval data published in 2012 revealed that the wear and tear, called impingement issues, have occurred in many designs, which can lead to accelerated wear and fatigue. This is particularly true for mobile bearing ball-in-socket type, fixed bearing ball-in-socket prostheses and elastomeric or compliant type prostheses. That is why ASTM has proposed a new international standard to help manufacturers improve design elements.

ASTM WK33006, “Guide for Impingement Testing of Total Disc Prostheses” is being developed to allow users to evaluate devices and determine the issues that lead to impingement.

ASTM committee F04 on Medical and Surgical Materials and Devices is responsible for the guidance, and the group welcomes members of the spinal community working on total disc replacement to join in the development of the proposed standard.

The aim is to develop preclinical fatigue and wear cycle tests for TDR parts made from polymeric, metallic or ceramic materials. These tests could inform regulatory assessments, as well as improve longevity and clinical performance of the devices. It could also unveil the next-generation design concepts and materials. Presently, there are no standards for total disc impingement.

The guidance committee acknowledges that there are many possible in vivo conditions that can influence TDR devices and that a laboratory simulation will not have universal applications. It is not their intent to address potential failures related to fixation of the implant to bony surfaces, for example. Nor does the scope of the guide enable comparisons of intervertebral disc prostheses with regard to kinematic, functional, and wear characteristics when tested under the specified conditions.

ASTM says it welcomes participation in the development of its standards. Here’s where you can go to become a member: www.astm.org/JOIN.

[Want to stay more on top of MDO content? Subscribe to our weekly e-newsletter.]

Related Articles Read More >

A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A portrait of Stryker executive Tracy Robertson
Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’
Stryker Mako robotic-arm assisted surgery robotic digital health medtech
How Stryker is advancing digital healthcare
Ariste Medical co-founder Lisa Jennings
Ariste Medical co-founder sees great potential for drug-coated implants and orthopedics

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech