# K113071: Synthecel Dura Replacement Devices

- Pathway: 510(k) (Traditional)
- Applicant: Synthes
- Decided: Jan 9, 2012 after 84 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: 4 generations back to K950956 (1995). 10 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K950956: Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute, Bio-Vascular, Inc. (1995) Summary page 1.
- K973706: Dura-Guard-Dural Repair Patch, Bio-Vascular, Inc. (1997) Summary page 1.
- K982282: Dura-Guard - Dural Repair Patch, Bio-Vascular, Inc. (1998) Summary page 1.
- K982180: Duragen Dural Graft Matrix, Integra Lifesciences Corp. (1999) Summary page 1.
- K021477: Preclude MVP Dura Substitute, W. L. Gore & Associates, Inc. (2002) Summary page 1.

## Most influential descendants
- K131792: Synthecel Dura Repair, Synthecel Dura Onlay (2013), 1 descendant of its own
- 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 Replacement Devices are intended for use as a dura replacement for the repair of dura mater. SyntheCel® Dura Onlay is indicated for use in adults for the repair of dural defects and it can be placed without sutures. SyntheCel® Dura Substitute is indicated for use in adults for the repair of dural defects and it can be sutured into place.

Source page: https://510kreport.com/device/K113071
Methodology: https://510kreport.com/methodology