PMA
P830055: LCS(R) TOTAL KNEE SYSTEM
FDA PMA · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing · Depuy, Inc.
Key facts
| PMA number | P830055 |
|---|---|
| Trade name | LCS(R) TOTAL KNEE SYSTEM |
| Generic name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Depuy, Inc. |
| Owner/operator | DePuy Synthes, Inc. |
| Product code | NJL |
| Approval date | Apr 12, 1985 |
| Docket number | 85M-0195 |
| Notice date | May 20, 1985 |
| Establishment registration | 8010379 |
| FEI number | 1000199976 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- No 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: