# K090803: Hanson Medical Facial Implants

- Pathway: 510(k) (Traditional)
- Applicant: Hanson Medical, Inc.
- Decided: Jun 30, 2010 after 463 days
- Product code: FZE (Prosthesis, Nose, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K952705 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973573: Duralastic Anatomical Nasal Implants, Hanson Medical, Inc. (1997) Summary page 3.
- K973574: Duralastic Anatomical Malar Implant, Hanson Medical, Inc. (1997) Summary page 3.
- K973575: Duralastic Anatomical Chin Implants, Hanson Medical, Inc. (1997) Summary page 3.

## Indications for use
Silicone Nasal Implant - For the augmentation or reconstruction of the nasal contour Silicone Malar Implant - For the augmentation or reconstruction of the malar contour Silicone Chin Implant -For the augmentation or reconstruction of the chin contour

Source page: https://510kreport.com/device/K090803
Methodology: https://510kreport.com/methodology