# K260245: SILKBridge

- Pathway: 510(k) (Traditional)
- Applicant: KLISBio S.r.l.
- Decided: Apr 9, 2026 after 72 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
SILKBridge is indicated for the surgical repair of peripheral nerve discontinuities of up to 10 mm.

Source page: https://510kreport.com/device/K260245
Methodology: https://510kreport.com/methodology