PMA
P010001: CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Ceramtec GmbH
Key facts
| PMA number | P010001 |
|---|---|
| Trade name | CERAMIC TRANSCEND HIP ARTICULATION SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Ceramtec GmbH |
| Owner/operator | CeramTec GmbH |
| Product code | MRA |
| Approval date | Feb 3, 2003 |
| Docket number | 03M-0332 |
| Notice date | Jul 30, 2003 |
| Establishment registration | 3008886124 |
| FEI number | 3008886124 |
At a glance
- 10–99 Supplements
- Jun 20, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: