# K181673: Rigi10 Malleable Penile Prosthesis

- Pathway: 510(k) (Abbreviated)
- Applicant: Rigicon, Inc.
- Decided: Apr 15, 2019 after 294 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
Longest line of descent: 2 generations back to K900371 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040959: Mentor Genesis Penile Prosthesis, Mentor Corp. (2004) Summary page 4.

## Indications for use
The malleable penile prosthesis is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse. The prosthesis is designed for the treatment of organic erectile dysfunction in men due to: Pelvic fracture,Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes mellitus, Arteriosclerosis,Hypertensive vascular disease,Priapism,Peyronie’s disease,Selectively for psychogenic impotence.

Source page: https://510kreport.com/device/K181673
Methodology: https://510kreport.com/methodology