# K212943: SyntheCel Dura Repair

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Jan 28, 2022 after 135 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: 6 generations back to K950956 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
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 4.
- K131792: Synthecel Dura Repair, Synthecel Dura Onlay, Synthes, Inc. (2013) Summary page 4.

## Indications for use
SYNTHECEL Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.

Source page: https://510kreport.com/device/K212943
Methodology: https://510kreport.com/methodology