# K180222: Reaxon Plus

- Pathway: 510(k) (Traditional)
- Applicant: Medovent GmbH
- Decided: Apr 24, 2018 after 89 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: 1 generation back to K011168 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001) Summary page 6.

## Indications for use
Reaxon Plus is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K180222
Methodology: https://510kreport.com/methodology