# K254126: Natrelle 133S Tissue Expanders

- Pathway: 510(k) (Special)
- Applicant: AbbVie
- Decided: Jan 16, 2026 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: 4 generations back to K011500 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182054: Natrelle 133S Tissue Expander, Allergan (2018) Summary page 5.

## Indications for use
The Natrelle® 133S Tissue Expander can be used for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. 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/K254126
Methodology: https://510kreport.com/methodology