# K140383: ALLOX2 Tissue Expanders

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products, Inc.
- Decided: Oct 28, 2014 after 256 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: 1 generation back to K801766 (1980). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070303: Silicone Tissue Expander, Specialty Surgical Products (2007) Summary page 4.
- K801766: Jackson-Pratt Large Vol. Closed Wound, American Heyer Schulte (1980) Summary page 4.

## Most influential descendants
- K214124: AlloX2 Pro Tissue Expanders (2023), 0 descendants of its own

## Indications for use
AlloX2 Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities. Additionally, the AlloX2 Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not replace short-term, immediate, intraoperatively placed drains.

Source page: https://510kreport.com/device/K140383
Methodology: https://510kreport.com/methodology