# K190246: NeuroShield

- Pathway: 510(k) (Traditional)
- Applicant: Monarch Bioimplants GmbH
- Decided: May 31, 2019 after 114 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 K850785 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103081: Covaortho-Nerve Resorbable Collagen Membrane, Biom'Up Sas (2012) Summary page 5.
- K143711: Reaxon Plus, Medovent GmbH (2015) Summary page 5.
- K152967: Nerbridge, Toyobo Co., Ltd. (2016) Summary page 5.

## Indications for use
Under supervision of a healthcare professional • NeuroShield[TM] is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K190246
Methodology: https://510kreport.com/methodology