# K143354: Natrelle 133 Plus Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Aug 20, 2015 after 269 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: 1 (1 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has 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
- K182054: Natrelle 133S Tissue Expander (2018), 1 descendant of its own
- K254126: Natrelle 133S Tissue Expanders (2026), 0 descendants of its own
- K180826: Natrelle 133 Plus MICROCELL Tissue Expander (2018), 0 descendants of its own

## Recalls of this device
- Jul 24, 2019 · Class I · Z-2456-2019: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in pat

## Indications for use
The Natrelle® 133 Plus 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/K143354
Methodology: https://510kreport.com/methodology