# K243836: Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander

- Pathway: 510(k) (Special)
- Applicant: Mentor Worldwide, LLC
- Decided: Jan 12, 2025 after 30 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011500 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241918: MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander, Mentor Worldwide, LLC (2024) Summary page 5.
- K152496: CPX 4 Breast Tissue Expander, Mentor Worldwide, LLC (2016) Summary page 5.

## 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/K243836
Methodology: https://510kreport.com/methodology