# K211676: Motiva Flora SmoothSilk Tissue Expander

- Pathway: 510(k) (Traditional)
- Applicant: Motiva USA, LLC
- Decided: Oct 13, 2023 after 864 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 K070303 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Motiva Flora® SmoothSilk® 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 reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.

Source page: https://510kreport.com/device/K211676
Methodology: https://510kreport.com/methodology