# K050573: Neurolac Nerve Guide

- Pathway: 510(k) (Traditional)
- Applicant: Polyganics B.V.,
- Decided: May 4, 2005 after 58 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: 2 generations back to K983007 (1999). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002098: Salumedica Nerve Cuff, Salumedica, LLC (2000) Summary page 1.
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001) Summary page 1.
- K032115: Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03, Polyganics B.V., (2003) Summary page 1.

## Most influential descendants
- K230794: Rebuilder Nerve Guidance Conduit (2024), 0 descendants of its own
- K152684: Nerve Capping Device (2016), 0 descendants of its own

## Indications for use
The Neurolac nerve guide is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.

Source page: https://510kreport.com/device/K050573
Methodology: https://510kreport.com/methodology