# K191130: Customized Contour Implant

- Pathway: 510(k) (Traditional)
- Applicant: Implantech Associates, Inc.
- Decided: Aug 23, 2019 after 116 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: 1 generation back to K913761 (1991). 1 ancestor in all.
2 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)
- K913761: 3-D Accuscan Facial Implants, Implantech Associates, Inc. (1991) Summary page 4.

## Most influential descendants
- K232593: FITme Customized Silicone Implant (2023), 0 descendants of its own
- K200610: Customized Contour Implant (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K191130
Methodology: https://510kreport.com/methodology