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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NamePatient Specific Talus Spacer
Classification Nameprosthesis, total talus replacement, metal
Generic Nameprosthesis, total talus replacement, metal
Paragon 28, Inc.
14445 grasslands dr.
englewood, CO 80112
HDE NumberH200001
Date Received06/30/2020
Decision Date02/17/2021
Product Code
QNN[ Registered Establishments with QNN ]
Docket Number 21M-0203
Notice Date 02/18/2021
Advisory Committee Orthopedic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the patient specific talus spacer. This device is indicated for avascular necrosis of the ankle joint. The anatomical landmarks necessary for the design and creation of the additive orthopaedics patient specific talus spacer must be present and identifiable on computed tomography (ct) scan.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005