510(k) · Cleared
Recalled · Class II · 2025Aart Pectoralis Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthetic and Reconstructive Technologies, Inc. · MIC Implant, Muscle, Pectoralis
Cleared on Jul 3, 2002 after a 68-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Jul 3, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- MIC
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Pectoralis Implant marketed by Allied Biomedical Corporation Named without a submission number | |
| * | — | Pectoralis Implant marketed by Seare Biomedical Corp. Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2025 | Class II | Z-0948-2026 | No Marketing Application | Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MIC devicesMIC Implant, Muscle, Pectoralis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIC
FDA has decided no MIC device since 2007.
Median 510(k) review, days · MIC
Too few MIC 510(k)s in any year since 2007 to give a median.
Recalls per year · MIC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIC
2in 2024
MAUDE reports naming product code MIC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021337 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021337: Aart Pectoralis Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021337
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026