# K090078: Kerasys Bioengineered Lamellar Patch Graft

- Pathway: 510(k) (Traditional)
- Applicant: Iop, Inc.
- Decided: May 8, 2009 after 116 days
- Product code: NXM (Prosthesis, Eyelid Spacer/Graft, Biologic)
- Device class: 2
- Regulation: 21 CFR 886.3130
- 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 K921895 (1992). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053622: Surgisis Ocular Graft, Iop, Inc. (2006) Summary page 2.
- K050246: Sis Dermal Augmentation Strand, Cook Biotech, Inc. (2005) Summary page 2.

## Most influential descendants
- K223074: CorNeat EverPatch (2023), 0 descendants of its own

## Indications for use
The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.

Source page: https://510kreport.com/device/K090078
Methodology: https://510kreport.com/methodology