# K060952: Collagen Nerve Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Jul 14, 2006 after 99 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). 5 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 28 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.
- K041620: Neura Wrap Nerve Protector, Integra Lifesciences Corp. (2004) Summary page 1.
- K850785: Fastube Nerve Regeneration Device, Research Medical, Inc. (1985) Summary page 1.

## Most influential descendants
- K080452: Collagen Tendon Wrap (2008), 15 descendants of its own
- K112423: Collagen Tendon Sheet (2011), 14 descendants of its own
- K201572: TAPESTRY Biointegrative Implant (2020), 5 descendants of its own
- K122048: Collagen Tendon Sheet-D (2013), 5 descendants of its own
- K140300: Collagen Tendon Sheet-Ddi (CTS-Ddi) (2014), 4 descendants of its own

## Indications for use
Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue and where gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K060952
Methodology: https://510kreport.com/methodology