# K983015: Virilis Penile Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products, Inc.
- Decided: Feb 5, 1999 after 161 days
- Product code: FTQ (Prosthesis, Penis, Rigid Rod)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.

Source page: https://510kreport.com/device/K983015
Methodology: https://510kreport.com/methodology