510(k) · Cleared
Recalled · Class II · 2025Aart Silicone Carving Block
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, 2 citing it directly.
- This deviceK021820 Aart Silicone Carving BlockAesthetic and Reconstructive Technologies, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK171851 SoftxilBistool · 2018
- Descendant · 2 generations on · 1 of its ownK193392 BioSiCar Silicone ImplantMetalware Technology Corp. · 2020
- Descendant · 2 generations on · 0 of its ownK241150 MISTI Silicone ImplantKeosan Trading Co. · 2024
- Descendant · 3 generations on · 0 of its ownK222748 ShiNeo Silicone ImplantShineo Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK071823 Perma Facial ImplantsSurgisil · 2007
Most influential descendants
Showing 5 of 5 · See all- K171851SoftxilBistool · 2018 · cites it directly3descendants
- K193392BioSiCar Silicone ImplantMetalware Technology Corp. · 2020 · 2 generations on1descendant
- K241150MISTI Silicone ImplantKeosan Trading Co. · 2024 · 2 generations on0descendants
- K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd. · 2022 · 3 generations on0descendants
- K071823Perma Facial ImplantsSurgisil · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021820 | Aart Silicone Carving Block | Aesthetic and Reconstructive Technologies, Inc. | 2002 | — |
| +1 | K171851 | Softxil | Bistool | 2018 | — |
| +2 | K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | 2020 | — |
| +2 | K241150 | MISTI Silicone Implant | Keosan Trading Co. | 2024 | — |
| +3 | K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | 2022 | — |
| +1 | K071823 | Perma Facial Implants | Surgisil | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | Silicone Carving Block marketed by Hanson Medical, Inc. Named without a submission number | |
| * | — | Spectrum Designs Pre-Form Contour Silicone Carving Block Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0944-2026 | 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, K171851 (Bistool, 2018) has gone furthest, with 3 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 Silicone Carving Block is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. The rectangular blocks are designed for carving flatter devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or surgery. The contoured blocks are generally used for carving curved devices such as nasals or malars or used in body contouring to minimize muscular defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021820 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021820: Aart Silicone Carving Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021820
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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