# K170656: Reinforced Flexible Collagen Nerve Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Jun 1, 2017 after 90 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 K850785 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131541: Flexible Cooagen Nerve Cuff, Collagen Matrix, Inc. (2014) Summary page 4.

## Indications for use
Reinforced Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries in discontinuities where gap closure can be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue).

Source page: https://510kreport.com/device/K170656
Methodology: https://510kreport.com/methodology