# K973574: Duralastic Anatomical Malar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Hanson Medical, Inc.
- Decided: Oct 24, 1997 after 35 days
- Product code: LZK (Implant, Malar)
- 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 K952707 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952707: Silicone Elastomer Malar Implant, Spirit Ridge Technologies (1995) Summary page 1.

## Most influential descendants
- K090803: Hanson Medical Facial Implants (2010), 0 descendants of its own

## Indications for use
To augment or reconstruct the malar cheek contour or the maxillary Zygoma.

Source page: https://510kreport.com/device/K973574
Methodology: https://510kreport.com/methodology