# K131541: Flexible Cooagen Nerve Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Apr 3, 2014 after 309 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 K850785 (1985). 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)
- K012814: Collagen Nerve Cuff, Collagen Matrix, Inc. (2001) Summary page 1.
- (no number) Silastic Nerve Cuff: named in the summary without a submission number

## Most influential descendants
- K170656: Reinforced Flexible Collagen Nerve Cuff (2017), 0 descendants of its own
- K152684: Nerve Capping Device (2016), 0 descendants of its own

## Indications for use
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) or at the end of the nerve in the foot to reduce the formation of symptomatic or painflul neuroma.

Source page: https://510kreport.com/device/K131541
Methodology: https://510kreport.com/methodology