# K070303: Silicone Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products
- Decided: Jun 22, 2007 after 142 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140383: ALLOX2 Tissue Expanders (2014), 1 descendant of its own
- K211676: Motiva Flora SmoothSilk Tissue Expander (2023), 0 descendants of its own
- K214124: AlloX2 Pro Tissue Expanders (2023), 0 descendants of its own

## Indications for use
Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aide in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.

Source page: https://510kreport.com/device/K070303
Methodology: https://510kreport.com/methodology