# K021820: Aart Silicone Carving Block

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic and Reconstructive Technologies, Inc.
- Decided: Jul 16, 2002 after 42 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Silicone Carving Block marketed by Hanson Medical, Inc.: named in the summary without a submission number
- (no number) Spectrum Designs Pre-Form Contour Silicone Carving Block: named in the summary without a submission number

## Most influential descendants
- K171851: Softxil (2018), 3 descendants of its own
- K193392: BioSiCar Silicone Implant (2020), 1 descendant of its own
- K241150: MISTI Silicone Implant (2024), 0 descendants of its own
- K222748: ShiNeo Silicone Implant (2022), 0 descendants of its own
- K071823: Perma Facial Implants (2007), 0 descendants of its own

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0944-2026: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

## Indications for use
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.

Source page: https://510kreport.com/device/K021820
Methodology: https://510kreport.com/methodology