# K021337: Aart Pectoralis Implant

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic and Reconstructive Technologies, Inc.
- Decided: Jul 3, 2002 after 68 days
- Product code: MIC (Implant, Muscle, Pectoralis)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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) Pectoralis Implant marketed by Allied Biomedical Corporation: named in the summary without a submission number
- (no number) Pectoralis Implant marketed by Seare Biomedical Corp.: named in the summary without a submission number

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0948-2026: 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 for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis nmuscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland’s Syndrome (congenitally absent pectoralis muscle).

Source page: https://510kreport.com/device/K021337
Methodology: https://510kreport.com/methodology