510(k) · Cleared
Recalled · Class II · 2025Aart Malar Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthetic and Reconstructive Technologies, Inc. · LZK Implant, Malar
Cleared on Jul 2, 2002 after a 60-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Jul 2, 2002
- Review
- 60 days
- Class
- Class II
- Product code
- LZK
- 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 LZK? 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 |
|---|---|---|---|
| * | — | Allied Biomedical Corporation Dmlastic Anatomical Malar Implants Named without a submission number | |
| * | — | Seare Biomedical Corp. Malar Implants 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-0947-2026 | 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 LZK devicesLZK Implant, Malar: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZK
FDA has decided no LZK device since 2007.
Median 510(k) review, days · LZK
Too few LZK 510(k)s in any year since 2007 to give a median.
Recalls per year · LZK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZK
1in 2022
MAUDE reports naming product code LZK, 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 | — | 3 | 10 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the AART Malar Implant is for augmentation or reconstruction of the cheek areas of the face.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021419 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021419: Aart Malar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021419
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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