# K232593: FITme Customized Silicone Implant

- Pathway: 510(k) (Traditional)
- Applicant: Keosan Trading Co.
- Decided: Nov 22, 2023 after 89 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913761 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191130: Customized Contour Implant, Implantech Associates, Inc. (2019) Summary page 5.

## Indications for use
The FITme Customized Silicone Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The FITme Customized Silicone Implant is pre-shaped to the surgeon’s specification to meet the needs of a particular patient.

Source page: https://510kreport.com/device/K232593
Methodology: https://510kreport.com/methodology