# K162624: Pre-Formed Penile Silicone Block

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Devices, Inc.
- Decided: Feb 1, 2017 after 134 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021839 (2002). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042380: Silicone Block, National Medical Devices, Inc. (2004) Summary page 5.
- K040042: Medisil Silicone Sheeting, Medisil Corporation (2004) Summary page 5.
- K022511: Aart Calf Implant, Aesthetic and Reconstructive Technologies, Inc. (2002) Summary page 5.
- K021839: Aart Gluteal Implant, Aesthetic and Reconstructive Technologies, Inc. (2002) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon’s discretion to create a custom implant.

Source page: https://510kreport.com/device/K162624
Methodology: https://510kreport.com/methodology