# K012814: Collagen Nerve Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Sep 21, 2001 after 30 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: 1 generation back to K850785 (1985). 3 ancestors in all.
37 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001) Summary page 1.
- K002098: Salumedica Nerve Cuff, Salumedica, LLC (2000) Summary page 1.
- K850785: Fastube Nerve Regeneration Device, Research Medical, Inc. (1985) Summary page 1.

## Most influential descendants
- K060952: Collagen Nerve Wrap (2006), 22 descendants of its own
- K080452: Collagen Tendon Wrap (2008), 15 descendants of its own
- K112423: Collagen Tendon Sheet (2011), 14 descendants of its own
- K031069: Surgisis Nerve Cuff (2003), 10 descendants of its own
- K132660: Nerve Cuff (2014), 6 descendants of its own

## Indications for use
Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K012814
Methodology: https://510kreport.com/methodology