# K022511: Aart Calf Implant

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic and Reconstructive Technologies, Inc.
- Decided: Aug 26, 2002 after 27 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; 1 cites 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) Silimed Calf Implant: named in the summary without a submission number

## Most influential descendants
- K162624: Pre-Formed Penile Silicone Block (2017), 4 descendants of its own
- K181387: Pre-Formed Penile Silicone Block (2019), 3 descendants of its own
- K220760: Pre-Formed Penile Silicone Block (2022), 1 descendant of its own
- K223051: Pre-Formed Silicone Block (2023), 0 descendants of its own
- K200073: AugMENTA Penile Implant (2022), 0 descendants of its own

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0949-2026: 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 Calf 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.

Source page: https://510kreport.com/device/K022511
Methodology: https://510kreport.com/methodology