# K060151: Orbital Tissue Expander (Ote)

- Pathway: 510(k) (Traditional)
- Applicant: Innovia, LLC
- Decided: Aug 8, 2006 after 200 days
- Product code: NFM (Expander, Tissue, Orbital)
- Device class: 2
- Regulation: 21 CFR 886.3320
- 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 K010852 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010852: Osmed Tissue Expander, Iop, Inc. (2001) Summary page 1.

## Most influential descendants
- K070130: Orbital Reconstructive Implant (2007), 1 descendant of its own
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own

## Indications for use
The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.

Source page: https://510kreport.com/device/K060151
Methodology: https://510kreport.com/methodology