# K182335: CPX 4 Breast Tissue Expander with Smooth Surface

- Pathway: 510(k) (Special)
- Applicant: Mentor Worldwide, LLC
- Decided: Sep 25, 2018 after 28 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: 2 generations back to K011500 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130813: Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders, Mentor Corp. (2013) Summary page 4.

## Most influential descendants
- K241918: MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (2024), 1 descendant of its own
- K243836: Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (2025), 0 descendants of its own

## Indications for use
The CPX™4 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/K182335
Methodology: https://510kreport.com/methodology