# K131792: Synthecel Dura Repair, Synthecel Dura Onlay

- Pathway: 510(k) (Traditional)
- Applicant: Synthes, Inc.
- Decided: Dec 16, 2013 after 181 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K950956 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113071: Synthecel Dura Replacement Devices, Synthes (2012) Summary page 1.

## Most influential descendants
- K212943: SyntheCel Dura Repair (2022), 0 descendants of its own

## Recalls of this device
- Dec 8, 2015 · Class II · Z-1385-2016: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporari
- Dec 8, 2015 · Class II · Z-1384-2016: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporari
- Dec 8, 2015 · Class II · Z-1383-2016: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporari
- Dec 8, 2015 · Class II · Z-1387-2016: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporari
- Dec 8, 2015 · Class II · Z-1386-2016: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporari

## Indications for use
SyntheCel® Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults. SyntheCel® Dura Onlay is intended for use as a dura replacement for the repair of dura mater in adults.

Source page: https://510kreport.com/device/K131792
Methodology: https://510kreport.com/methodology