# K153613: Cerafix Dura Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Acera Surgical, Inc.
- Decided: Mar 16, 2016 after 90 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: 2 generations back to K950956 (1995). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991413: Codman Ethisorb Dura Patch, Johnson & Johnson Professionals, Inc. (2000) Summary page 4.

## Most influential descendants
- K161278: Cerafix Dura Substitute (2016), 6 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own
- K193583: Restrata® (2020), 1 descendant of its own
- K254256: LUOFUCON® Wound Matrix (2026), 0 descendants of its own
- K260020: Redermo Wound Matrix (2026), 0 descendants of its own

## Indications for use
The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in2 (12.5 cm2) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 cm) would be an acceptable defect size.

Source page: https://510kreport.com/device/K153613
Methodology: https://510kreport.com/methodology