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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade Name4WEB Medical Talar Replacement Device
Classification Nameprosthesis, total talus replacement, metal
Generic Nameprosthesis, total talus replacement, metal
Applicant
Stryker
1023 cherry rd.
memphis, TN 38117
HDE NumberH240001
Supplement NumberS001
Date Received01/28/2025
Decision Date03/20/2025
Product Code
QNN[ Registered Establishments with QNN ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The 4web medical talar replacement device is indicated for avascular necrosis of the talus adult patients requiring replacement. The anatomical landmarks necessary for the design and creation of the 4web medical talar replacement device must be present and identifiable on computed tomography scan.
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