# K230794: Rebuilder Nerve Guidance Conduit

- Pathway: 510(k) (Traditional)
- Applicant: Celestray Biotech Company, LLC.,
- Decided: Jan 29, 2024 after 313 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: 3 generations back to K983007 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112267: Neurolac (R) Nerve Guide, Polyganics B.V., (2011) Summary page 5.
- K050573: Neurolac Nerve Guide, Polyganics B.V., (2005) Summary page 5.

## Indications for use
Rebuilder Nerve Guidance Conduit 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/K230794
Methodology: https://510kreport.com/methodology