# K161176: ARTOURA Breast Tissue Expanders with Smooth Surface

- Pathway: 510(k) (Special)
- Applicant: Mentor Worldwide, LLC
- Decided: May 23, 2016 after 27 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011500 (2001). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150777: Artoura Breast Tissue Expander, Mentor Worldwide, LLC (2015) Summary page 4.

## Most influential descendants
- K244026: PAL 7020 Console (2025), 0 descendants of its own
- K242963: MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (2025), 0 descendants of its own

## Recalls of this device
- Feb 18, 2026 · Class II · Z-1687-2026: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Feb 18, 2026 · Class II · Z-1686-2026: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

## Indications for use
MENTOR ® ARTOURA™ Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Source page: https://510kreport.com/device/K161176
Methodology: https://510kreport.com/methodology