# K991413: Codman Ethisorb Dura Patch

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Mar 13, 2000 after 325 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- 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 K950956 (1995). 2 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950956: Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute, Bio-Vascular, Inc. (1995) Summary page 1.
- K960470: Neuro-Patch, Aesculap, Inc. (1996) Summary page 1.

## Most influential descendants
- K153613: Cerafix Dura Substitute (2016), 7 descendants of its own
- K161278: Cerafix Dura Substitute (2016), 6 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own
- K033395: Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 (2004), 2 descendants of its own
- K031850: Durasis Dural Substitute (2003), 2 descendants of its own

## Indications for use
The CODMAN ETHISORB™ Dura Patch is an absorbable, synthetic implant for bridging defects of the dura mater.

Source page: https://510kreport.com/device/K991413
Methodology: https://510kreport.com/methodology