Requests that the FDA reclassify the VariTrax Sternal CircumFixation System (K232986) and/or require the manufacturer or any clinicians using the device to apply for an investigational device exemption (IDE) to continue its clinical use in human patients. The FDA should also require postmarket surveillance of patients in whom VariTrax has been implanted. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-2105

Requests that the FDA reclassify the VariTrax Sternal CircumFixation System (K232986) and/or require the manufacturer or any clinicians using the device to apply for an investigational device exemption (IDE) to continue its clinical use in human patients. The FDA should also require postmarket surveillance of patients in whom VariTrax has been implanted.

Documents

Comments

Key Dates

Comment Period OpensJul 3, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response	Dec 19, 2025	--

Comment Statistics

Total Comments

Keywords

CDRH

Citizen Petition

Harmed Americans

for Reform in Medical-Device Safety Corp

reclassify

the VariTrax as a Class III medical device

require the manufacturer of

VariTrax to apply for and receive IDE to

Data from Regulations.gov