510(k) · Cleared
Recalled · Class II · 2025Aart Gluteal Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthetic and Reconstructive Technologies, Inc. · MIB Elastomer, Silicone Block
Cleared on Jul 16, 2002 after a 42-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 16, 2002
- Review
- 42 days
- Class
- Class II
- Product code
- MIB
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK021839 Aart Gluteal ImplantAesthetic and Reconstructive Technologies, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK162624 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK181387 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK220760 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK223051 Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK200073 AugMENTA Penile ImplantAugmenta, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K162624Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017 · cites it directly4descendants
- K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019 · 2 generations on3descendants
- K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022 · 3 generations on1descendant
- K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023 · 2 generations on0descendants
- K200073AugMENTA Penile ImplantAugmenta, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021839 | Aart Gluteal Implant | Aesthetic and Reconstructive Technologies, Inc. | 2002 | — |
| +1 | K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017 | — |
| +2 | K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019 | — |
| +3 | K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022 | — |
| +2 | K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | 2023 | — |
| +3 | K200073 | AugMENTA Penile Implant | Augmenta, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
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 MIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MIB device
- #1 K241150 MISTI Silicone Implantscore 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Silimed Gluteal Implant Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162624 | Pre-Formed Penile Silicone Block | 2017 | 4 |
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-0945-2026 | 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.
What does this lineage say?
- Of its descendants, K162624 (International Medical Devices, Inc., 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIB
102in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIB
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIB
18in 2025
MAUDE reports naming product code MIB, 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 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 3 | 102 | 0 | 19 |
| 2023 | 1 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 3 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the AART Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021839 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021839: Aart Gluteal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021839
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026