# K082006: Ams Spectra Concealable Penile Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Oct 20, 2008 after 97 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: 1 generation back to K912935 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953640: Duna II Penile Prosthesis, Dacomed Corp. (1995) Summary page 1.
- K912935: Ams Malleable 600 and 600M Penile Prosthesis, American Medical Systems, Inc. (1992) Summary page 1.
- K951716: Ams 650 Mallerable Peniel Prosthesis, American Medical Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K090663: Ams Spectra Concealable Penile Prosthesis (2009), 0 descendants of its own

## Indications for use
The AMS Spectra TM Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in.men who are determined to be suitable candidates for implantation surgery.

Source page: https://510kreport.com/device/K082006
Methodology: https://510kreport.com/methodology