# K122791: Lyoplant Onlay

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jun 4, 2013 after 265 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: 5 generations back to K950956 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970851: Lyoplant Dura Substitute (Various), Aesculap, Inc. (1997) Summary page 3.
- K043427: Duragen II Dural Regeneration Matrix, Integra Lifesciences Corp. (2005) Summary page 3.
- K041000: Durepair Dura Regeneration Matrix, Medtronic Neurosurgery (2004) Summary page 3.

## Indications for use
Lyoplant® Onlay is indicated as a dura substitute for the repair of the dura mater.

Source page: https://510kreport.com/device/K122791
Methodology: https://510kreport.com/methodology