# K150777: Artoura Breast Tissue Expander

- Pathway: 510(k) (Special)
- Applicant: Mentor Worldwide, LLC
- Decided: Apr 24, 2015 after 30 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: 3 generations back to K011500 (2001). 3 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K142998: CPX Control Breast Tissue Expander, Mentor Worldwide, LLC (2014) Summary page 4.

## Most influential descendants
- K161176: ARTOURA Breast Tissue Expanders with Smooth Surface (2016), 2 descendants of its own
- 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-1685-2026: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Aug 9, 2016 · Class II · Z-2780-2016: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

## Indications for use
The Artoura (TM) Breast Tissue Expanders 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/K150777
Methodology: https://510kreport.com/methodology