This article is more than 5 years old. Information may no longer be current.

DT MedTech receives 510(k) FDA clearance for total ankle replacement system

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

DT MedTech LLC announced it has received FDA 510(k) clearance for the Hintermann Series H2 total ankle replacement system.

According to a company press release, the system is a semi-constrained total ankle replacement prosthesis developed by Beat Hintermann, MD, and is to be used with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis, primary arthritis or secondary arthritis. The Hintermann Series H2 is also to be used in patients with a failed total ankle replacement or nonunion/malunion of ankle arthrodesis in cases with sufficient bone stock.

The sales and distribution of the system in the United States will be handled by HealthLink Europe International from its U.S. headquarters in Raleigh, North Carolina.

“We are extremely pleased to receive marketing clearance from the FDA for our innovative Hintermann Series H2 total ankle replacement system,” David Reicher, president and CEO of DT MedTech, said in the release. “I want to thank our employees, M Squared Associates and other advisors and key stakeholders, who were all so instrumental in helping DT MedTech achieve this momentous milestone.”

Reference:

dtmedtech.com/