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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 Namerestor3d Total Talus Replacement
Classification Nameprosthesis, total talus replacement, metal
Generic Nameprosthesis, total talus replacement, metal
Applicant
restor3d, Inc.
311 w. corporation street
durham, NC 27701
HDE NumberH230003
Date Received06/02/2023
Decision Date11/17/2023
Product Code
QNN[ Registered Establishments with QNN ]
Docket Number 23M-5210
Notice Date 12/01/2023
Advisory Committee Orthopedic
Clinical Trials NCT05231304
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the restor3d total talus replacement. The restor3d total talus replacement implant is indicated for:• avascular necrosis of the talus• avascular necrosis of the talus in addition to talar collapse, cysts or non-union• large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments• non-union following talar fracture or talar extrusion, unresponsive to more conservative treatmentsthe implant is patient specific and is designed from computed tomography (ct) scan. The anatomical landmarks necessary for the design and creation of the restor3d total talus replacement implant must be present and identifiable on ct scan.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 
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