# K223051: Pre-Formed Silicone Block

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Devices, Inc.
- Decided: Feb 3, 2023 after 127 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: 4 generations back to K021839 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 4.
- K220760: Pre-Formed Penile Silicone Block, International Medical Devices, Inc. (2022) Summary page 4.
- K162624: Pre-Formed Penile Silicone Block, International Medical Devices, Inc. (2017) Summary page 4.
- K181387: Pre-Formed Penile Silicone Block, International Medical Devices, Inc. (2019) Summary page 4.

## Indications for use
The Pre-Formed 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 to aid in the reconstruction process.

Source page: https://510kreport.com/device/K223051
Methodology: https://510kreport.com/methodology