Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart D — Prosthetic Devices](/submissions/GU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 876.3630](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3630) → FAE — Prosthesis, Penile # FAE · Prosthesis, Penile _Gastroenterology, Urology · 21 CFR 876.3630 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE ## Overview - **Product Code:** FAE - **Device Name:** Prosthesis, Penile - **Regulation:** [21 CFR 876.3630](/submissions/GU/subpart-d%E2%80%94prosthetic-devices/876.3630) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **Implant:** yes ## Identification A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction. ## Classification Rationale Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.” ## Special Controls The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.” ## Recent Cleared Devices (20 of 32) Showing 20 most recent of 32 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K183619](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K183619.md) | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | Boston Scientific Corporation | Apr 16, 2019 | SESE | | [K181673](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K181673.md) | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | Apr 15, 2019 | SESE | | [K090663](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K090663.md) | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Apr 9, 2009 | SESE | | [K082006](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K082006.md) | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | Oct 20, 2008 | SESE | | [K040959](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K040959.md) | MENTOR GENESIS PENILE PROSTHESIS | Mentor Corp. | Oct 29, 2004 | SESE | | [K963328](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K963328.md) | AMS AMBICOR PENILE PROSTHESIS | American Medical Systems, Inc. | Dec 4, 1996 | SESE | | [K953640](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K953640.md) | DUNA II PENILE PROSTHESIS | Dacomed Corp. | Oct 27, 1995 | SESE | | [K951716](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K951716.md) | AMS 650 MALLERABLE PENIEL PROSTHESIS | American Medical Systems, Inc. | Jul 6, 1995 | SESE | | [K920420](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K920420.md) | DURA II PENILE PROSTHESIS | Dacomed Corp. | Apr 16, 1992 | SESE | | [K912935](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K912935.md) | AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS | American Medical Systems, Inc. | Mar 18, 1992 | SESE | | [K912344](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K912344.md) | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | Dacomed Corp. | Oct 11, 1991 | SESE | | [K910214](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K910214.md) | AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS | American Medical Corp. | Apr 25, 1991 | SESE | | [K904262](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K904262.md) | MINNOW PENILE IMPLANT PROTECTOR | Ruja-Med Medical Marketing | Dec 13, 1990 | SESE | | [K900371](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K900371.md) | MENTOR MODIFIED MALLEABLE PENILE PROSTHESES | Mentor Corp. | Nov 2, 1990 | SESE | | [K901482](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K901482.md) | 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER | American Medical Systems, Inc. | Jun 27, 1990 | SESE | | [K896941](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K896941.md) | AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS | American Medical Systems, Inc. | Mar 6, 1990 | SESE | | [K890402](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K890402.md) | MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) | Mentor Corp. | Aug 3, 1989 | SESE | | [K871653](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K871653.md) | DURAPHASE PENILE PROSTHESIS | Dacomed Corp. | Sep 18, 1987 | SESE | | [K864040](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K864040.md) | BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS | C.R. Bard, Inc. | Oct 24, 1986 | SESE | | [K860517](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE/K860517.md) | MENTOR CORPORAL DILATORS | Mentor Corp. | Mar 11, 1986 | SESE | ## Top Applicants - American Medical Systems, Inc. — 11 clearances - Dacomed Corp. — 7 clearances - Mentor Corp. — 5 clearances - Medical Engineering Corp. — 2 clearances - Surgitek — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE](https://fda.innolitics.com/submissions/GU/subpart-d%E2%80%94prosthetic-devices/FAE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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