# K103081: Covaortho-Nerve Resorbable Collagen Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Biom'Up Sas
- Decided: Mar 2, 2012 after 500 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). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060952: Collagen Nerve Wrap, Collagen Matrix, Inc. (2006) Summary page 1.
- K041620: Neura Wrap Nerve Protector, Integra Lifesciences Corp. (2004) Summary page 1.
- K011168: Neurogen Nerve Guide, Integra Lifesciences Corp. (2001) Summary page 1.

## Most influential descendants
- K152967: Nerbridge (2016), 1 descendant of its own
- K190246: NeuroShield (2019), 0 descendants of its own
- K130428: Covamesh (2013), 0 descendants of its own

## Indications for use
Indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.

Source page: https://510kreport.com/device/K103081
Methodology: https://510kreport.com/methodology