# K163457: NeuraGen 3D Nerve Guide Matrix

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Jan 6, 2017 after 28 days
- Product code: JXI (Cuff, Nerve)
- Device class: 2
- Regulation: 21 CFR 882.5275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K881854 (1988). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130557: Neuragen 3D, Integra LifeSciences Corporation (2014) Summary page 4.

## Indications for use
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K163457
Methodology: https://510kreport.com/methodology