Product code
NJL: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
FDA product code · Class III · Orthopedic
Key facts
| Product code | NJL |
|---|---|
| Device | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
| Device class | Class III |
| Review panel | Orthopedic |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 100–999 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database