PMA
P210034: Agili-C
FDA PMA · Implant, resorbable, for articular osteochondral repair · Smith and Nephew, Inc.
Key facts
| PMA number | P210034 |
|---|---|
| Trade name | Agili-C |
| Generic name | Implant, resorbable, for articular osteochondral repair |
| Applicant | Smith and Nephew, Inc. |
| Owner/operator | Smith & Nephew, Inc. |
| Product code | QRU |
| Approval date | Mar 29, 2022 |
| Docket number | 22M-0481 |
| Notice date | Mar 30, 2022 |
| Establishment registration | 3013881076 |
| FEI number | 3013881076 |
At a glance
- 1–9 Supplements
- Jun 4, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: