# K200073: AugMENTA Penile Implant

- Pathway: 510(k) (Traditional)
- Applicant: Augmenta, LLC
- Decided: Sep 30, 2022 after 990 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: 3 generations back to K021839 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181387: Pre-Formed Penile Silicone Block, International Medical Devices, Inc. (2019) Summary page 4.

## Indications for use
The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.

Source page: https://510kreport.com/device/K200073
Methodology: https://510kreport.com/methodology