PMA
P060037: NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
FDA PMA · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing · Zimmer, Inc.
Key facts
| PMA number | P060037 |
|---|---|
| Trade name | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM |
| Generic name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Zimmer, Inc. |
| Owner/operator | ZIMMER, INC. |
| Product code | NJL |
| Approval date | Dec 10, 2007 |
| Docket number | 08M-0522 |
| Notice date | Sep 26, 2008 |
| Establishment registration | 1822565 |
| FEI number | 1000220733 |
At a glance
- 10–99 Supplements
- Sep 24, 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- No Withdrawn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: