# K021419: Aart Malar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic and Reconstructive Technologies, Inc.
- Decided: Jul 2, 2002 after 60 days
- Product code: LZK (Implant, Malar)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Allied Biomedical Corporation Dmlastic Anatomical Malar Implants: named in the summary without a submission number
- (no number) Seare Biomedical Corp. Malar Implants: named in the summary without a submission number

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0947-2026: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

## Indications for use
The intended use of the AART Malar Implant is for augmentation or reconstruction of the cheek areas of the face.

Source page: https://510kreport.com/device/K021419
Methodology: https://510kreport.com/methodology