# K171851: Softxil

- Pathway: 510(k) (Traditional)
- Applicant: Bistool
- Decided: Mar 16, 2018 after 268 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: 1 generation back to K021820 (2002). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021820: Aart Silicone Carving Block, Aesthetic and Reconstructive Technologies, Inc. (2002) Summary page 5.

## Most influential descendants
- K193392: BioSiCar Silicone Implant (2020), 1 descendant of its own
- K241150: MISTI Silicone Implant (2024), 0 descendants of its own
- K222748: ShiNeo Silicone Implant (2022), 0 descendants of its own

## Indications for use
SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.

Source page: https://510kreport.com/device/K171851
Methodology: https://510kreport.com/methodology