AART Pectoralis Implant

• • Ongoing Z-0948-2026 FDA Class II ·initiated 26 Sep 2025

  Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.

510(k) Number

K021337 ↗

FDA Product Code

MIC

Device Class

Class II

Regulation

21 CFR Part 874.3620

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from Aesthetic and Reconstructive Technologies, Inc. →

• What is the AART Pectoralis Implant used for?

  The AART Pectoralis Implant is designed for submuscular placement to augment or reconstruct the pectoralis muscle. It is particularly intended for cases of Poland Syndrome, where one side of the chest is underdeveloped, or for chest contouring procedures. The convex oval shape allows it to integrate beneath the muscle for a natural enhancement.

• How is the AART Pectoralis Implant supplied and prepared for use?

  The implant is supplied sterile and intended for single-use only. It must be handled following strict sterile medical device protocols to ensure safety and efficacy. The packaging is designed to maintain sterility until surgical implantation by a qualified surgeon.

• Are there different sizes or styles available for the AART Pectoralis Implant?

  Yes, the AART Pectoralis Implant comes in three distinct styles, each with left and right mirror-image variants to accommodate anatomical differences. This ensures a tailored fit for patients requiring augmentation or reconstruction.

• Can the AART Pectoralis Implant be reused?

  No, the AART Pectoralis Implant is explicitly designed for single-use only. Reuse violates sterility protocols and could compromise patient safety, as it is supplied sterile and intended for one-time surgical implantation.

• What storage and handling requirements apply to the AART Pectoralis Implant?

  The implant must be stored and handled according to sterile medical device protocols to preserve its integrity and sterility. It should be kept in its original packaging until ready for use in a controlled surgical environment. Improper storage could compromise its safety and effectiveness.