# K040959: Mentor Genesis Penile Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corp.
- Decided: Oct 29, 2004 after 199 days
- Product code: FAE (Prosthesis, Penile)
- Device class: 2
- Regulation: 21 CFR 876.3630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900371 (1990). 1 ancestor in all.
1 later device descends 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)
- K900371: Mentor Modified Malleable Penile Prostheses, Mentor Corp. (1990) Summary page 1.

## Most influential descendants
- K181673: Rigi10 Malleable Penile Prosthesis (2019), 0 descendants of its own

## Recalls of this device
- Apr 9, 2015 · Class II · Z-1538-2015: Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the in

## Indications for use
The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; cystectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

Source page: https://510kreport.com/device/K040959
Methodology: https://510kreport.com/methodology