# K172603: Cerafix Dura Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Acera Surgical, Inc.
- Decided: Nov 27, 2017 after 89 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: 4 generations back to K950956 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040888: Duramatrix Collagen Dura Substitute Membrane, Collagen Matrix, Inc. (2004) Summary page 4.

## 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 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.

Source page: https://510kreport.com/device/K172603
Methodology: https://510kreport.com/methodology