# K241918: MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander

- Pathway: 510(k) (Special)
- Applicant: Mentor Worldwide, LLC
- Decided: Aug 2, 2024 after 32 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: 3 (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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152496: CPX 4 Breast Tissue Expander, Mentor Worldwide, LLC (2016) Summary page 5.
- K182335: CPX 4 Breast Tissue Expander with Smooth Surface, Mentor Worldwide, LLC (2018) Summary page 5.

## Most influential descendants
- K243836: Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (2025), 0 descendants of its own

## Recalls of this device
- Feb 18, 2026 · Class II · Z-1682-2026: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Feb 18, 2026 · Class II · Z-1684-2026: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Feb 18, 2026 · Class II · Z-1683-2026: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

## Indications for use
The Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

Source page: https://510kreport.com/device/K241918
Methodology: https://510kreport.com/methodology