FDA product code NJA: Accessory, System, External Fixator, Containing Antimicrobial Agent
NJA is the FDA product code for accessory, system, external fixator, containing antimicrobial agent. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. Devices under NJA reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones. The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire.
Classification
| Field | Value |
|---|---|
| Device name | Accessory, System, External Fixator, Containing Antimicrobial Agent |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for NJA devices
openFDA lists no recalls for product code NJA.
Frequently asked questions
What is FDA product code NJA?
NJA is the FDA product code for accessory, system, external fixator, containing antimicrobial agent. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is NJA?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NJA
- Run a recall and safety report across every NJA manufacturer
- Watch product code NJA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.