# K130813: Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders

- Pathway: 510(k) (Special)
- Applicant: Mentor Corp.
- Decided: Apr 11, 2013 after 17 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011500 (2001). 1 ancestor in all.
13 later devices descend from it; 4 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011500: Mentor Contour Profile Tissue Expander, Mentor Corp. (2001) Summary page 1.

## Most influential descendants
- K142998: CPX Control Breast Tissue Expander (2014), 4 descendants of its own
- K143354: Natrelle 133 Plus Tissue Expander (2015), 3 descendants of its own
- K150777: Artoura Breast Tissue Expander (2015), 3 descendants of its own
- K182335: CPX 4 Breast Tissue Expander with Smooth Surface (2018), 2 descendants of its own
- K161176: ARTOURA Breast Tissue Expanders with Smooth Surface (2016), 2 descendants of its own

## Recalls of this device
- Feb 18, 2026 · Class II · Z-1681-2026: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Aug 9, 2016 · Class II · Z-2748-2016: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
- Aug 9, 2016 · Class II · Z-2747-2016: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
- Aug 9, 2016 · Class II · Z-2781-2016: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

## Indications for use
The Contour Profile 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/K130813
Methodology: https://510kreport.com/methodology