Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

FDA gives ankle implant humanitarian nod

February 18, 2021 By Danielle Kirsh

talus-implantAdditive Orthopedics yesterday said it received FDA humanitarian device exemption for its Patient Specific Talus Spacer to treat avascular necrosis of the talus.

The Patient Specific Talus Spacer will be available as a humanitarian use device to treat avascular necrosis of the ankle joint, which is a serious condition that causes the death of bone tissue stemming from a lack of blood supply to the area.

“Avascular necrosis of the ankle, while a rare condition, is a serious and potentially debilitating one that causes pain and can lead to inhibited motion of the ankle joint, and in some cases, removal of part of the leg,” Raquel Peat, director of the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices, said in a news release. “Today’s action provides patients with a treatment option that could potentially reduce pain, retain range of motion of their joint and improve quality of life.”

Additive Orthopedics’s Patient Specific Talus Spacer is a 3D printed implant that can be used in talus replacement surgery. It is made for each patient individually, modeled from computer tomography imaging to fit a patient’s specific anatomy. During the procedure, a patient’s talus bone is removed and replaced with the 3D printed implant, which is made from cobalt chromium alloy.

“Avascular necrosis of the talus is extremely painful and debilitating for these patients. Surgical treatment options are below-the-knee amputation or joint fusion, which results in loss of motion of the ankle and can have poor outcomes. The Patient Specific Talus Spacer is another example of how 3D printed devices can improve the standard of care,” president Greg Kowalczyk said in a news release. “This is a tremendous regulatory win which took significant effort from our team and I want to thank everyone, including the U.S. Food and Drug Administration, who assisted in making this technology commercially available in the domestic market for patients suffering from AVN.”

The company will immediately market and commercially launch the implant.

About The Author

Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

Related Articles Read More >

A photo of Highridge Medical CEO Rebecca Whitney.
Highridge Medical is betting on this spine tech
Big 100: Stryker logo - Largest Medical Device Companies
Stryker pay climbs for top execs and median worker as sales break $20B mark
A titanium 3D printing close-up showing the complex surface geometry of an orthopedic implant.
3D printing with titanium: 5 questions with Riccardo Toninato at Enovis
An image of the July 2024 Medical Design & Outsourcing magazine cover featuring an astronaut with a surgical robot aboard the International Space Station.
July 2024 edition: Miniaturization at Virtual Incision and Tandem Diabetes; Orthobond’s antimicrobial tech; Largest ortho companies
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

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

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
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • 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 our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. 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
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe