# K900371: Mentor Modified Malleable Penile Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Nov 2, 1990 after 280 days
- Product code: FAE (Prosthesis, Penile)
- Device class: 2
- Regulation: 21 CFR 876.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040959: Mentor Genesis Penile Prosthesis (2004), 1 descendant of its own
- K181673: Rigi10 Malleable Penile Prosthesis (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K900371
Methodology: https://510kreport.com/methodology