# K161278: Cerafix Dura Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Acera Surgical, Inc.
- Decided: Aug 8, 2016 after 94 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: 3 generations back to K950956 (1995). 4 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K153613: Cerafix Dura Substitute, Acera Surgical, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K223445: ArtiFascia (2023), 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 4.4 in2 (28.3 cm2) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.

Source page: https://510kreport.com/device/K161278
Methodology: https://510kreport.com/methodology