HDE
H010005: ASCENSION PIP
FDA Humanitarian Device Exemption · Smith & Nephew, Inc.
Key facts
| HDE number | H010005 |
|---|---|
| Trade name | ASCENSION PIP |
| Generic name | High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis |
| Applicant | Smith & Nephew, Inc. |
| Owner/operator | Smith & Nephew, Inc. |
| Product code | OMX |
| Approval date | Mar 22, 2002 |
| Docket number | 02M-0121 |
| Establishment registration | 1020279 |
| FEI number | 1020279 |
At a glance
- 10–99 Supplements
- Dec 23, 2025 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: