# K102999: Trimotion Injector

- Pathway: 510(k) (Traditional)
- Applicant: Kaneka Corp.
- Decided: Dec 29, 2011 after 447 days
- Product code: OTZ (Graft Insertion Instrument For Endothelial Keratoplasty)
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K090626 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090626: Endoserter, Ocular Systems, Inc. (2011). Cleared while this submission was under review Summary page 1.

## Indications for use
The Kaneka TrimotionTM Injector is indicated for insertion and placement of donor corneal tissue (diameter: < 8.5 mm; thickness: 0.115-0.200 mm) into the anterior chamber of the recipient eye through a minimum 5.5 mm incision during a Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure.

Source page: https://510kreport.com/device/K102999
Methodology: https://510kreport.com/methodology