HDE supplement
H200001 S008: Patient Specific Talus Spacer
FDA HDE supplement · normal 75 day track · Paragon 28, Inc.
Key facts
| Original HDE | H200001 |
|---|---|
| Supplement number | S008 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | Patient Specific Talus Spacer |
| Generic name | Prosthesis, total talus replacement, metal |
| Applicant | Paragon 28, Inc. |
| Product code | QNN |
| Received date | Dec 15, 2025 |
| Decision date | Feb 24, 2026 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: