# K193392: BioSiCar Silicone Implant

- Pathway: 510(k) (Traditional)
- Applicant: Metalware Technology Corp.
- Decided: Jul 20, 2020 after 227 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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 K021820 (2002). 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)
- K171851: Softxil, Bistool (2018) Summary page 4.

## Most influential descendants
- K222748: ShiNeo Silicone Implant (2022), 0 descendants of its own

## Indications for use
BioSiCar Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour.

Source page: https://510kreport.com/device/K193392
Methodology: https://510kreport.com/methodology