# K102806: Natrelle 133 Tissue Expander with Suture Tabs

- Pathway: 510(k) (Special)
- Applicant: Allergan Medical
- Decided: Jan 5, 2011 after 99 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862203 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862203: Mcghan Magna-Site (TM) Tissue Expander, Mcghan Medical Corp. (1986) Summary page 1.

## Most influential descendants
- K112534: Lifecell Tissue Expander (2012), 0 descendants of its own

## Recalls of this device
- Jul 24, 2019 · Class I · Z-2455-2019: 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
- Jul 24, 2019 · Class I · Z-2457-2019: 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® Tissue Expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expanders are intended for temporary subcutaneous implantation and are not intended for use beyond six months.

Source page: https://510kreport.com/device/K102806
Methodology: https://510kreport.com/methodology