PMA
P010014: OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
FDA PMA · Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing · Biomet Manufacturing Corp
Key facts
| PMA number | P010014 |
|---|---|
| Trade name | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM |
| Generic name | Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Biomet Manufacturing Corp |
| Owner/operator | Zimmer Inc |
| Product code | NRA |
| Approval date | Apr 21, 2004 |
| Docket number | 04M-0200 |
| Notice date | May 5, 2004 |
| Establishment registration | 1825034 |
| FEI number | 1825034 |
At a glance
- 100–999 Supplements
- Oct 6, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: