PMA
P910016: NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
FDA PMA · Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing · Depuy, Inc.
Key facts
| PMA number | P910016 |
|---|---|
| Trade name | NEW JERSEY LCS(R) TOTAL KNEE SYSTEM |
| Generic name | Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Depuy, Inc. |
| Owner/operator | DePuy Synthes, Inc. |
| Product code | NRA |
| Approval date | Oct 30, 1992 |
| Docket number | 92M-0446 |
| Notice date | Apr 26, 1993 |
| Establishment registration | 1818910 |
| FEI number | 1818910 |
At a glance
- 10–99 Supplements
- Dec 12, 2005 Latest supplement decision
- Yes Withdrawn
- No 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: