510(k) · Cleared
Recalled · Class II · 2015Mentor Genesis Penile Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · FAE Prosthesis, Penile
Cleared on Oct 29, 2004 as substantially equivalent to K900371 (Mentor Corp., 1990) after a 199-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 29, 2004
- Review
- 199 days
- Class
- Class II
- Product code
- FAE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900371 (1990). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K181673Rigi10 Malleable Penile ProsthesisRigicon, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900371 | Mentor Modified Malleable Penile Prostheses | Mentor Corp. | 1990 | — |
| 0 (this device) | K040959 | Mentor Genesis Penile Prosthesis | Mentor Corp. | 2004 | — |
| +1 | K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900371 | Mentor Modified Malleable Penile ProsthesesSummary page 1…Equivalence Claim The Mentor Genesis Penile Prosthesis is essentially identical in design and function to Mentor's Acu-Form Penile Prosthesis (5 10(k) K900371) with the exception that it has been modified to incorporate a hydrophilic coating. This coating was previously submitte… | 1990 |
| † | P000006 | Titan Inflatable Penile Prosthesis | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181673 | Rigi10 Malleable Penile Prosthesis | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2015 | Class II | Z-1538-2015 | Error in labeling | 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 individual prosthesis tray during the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K181673 (Rigicon, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FAE devicesFAE Prosthesis, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAE
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FAE
Too few FAE 510(k)s in any year since 2007 to give a median.
Recalls per year · FAE
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAE
195in 2025
MAUDE reports naming product code FAE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 87 |
| 2012 | 0 | — | 0 | 97 |
| 2013 | 0 | — | 0 | 108 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 0 | — | 0 | 98 |
| 2016 | 0 | — | 0 | 104 |
| 2017 | 0 | — | 0 | 123 |
| 2018 | 0 | — | 0 | 127 |
| 2019 | 2 | — | 0 | 221 |
| 2020 | 0 | — | 0 | 163 |
| 2021 | 0 | — | 0 | 167 |
| 2022 | 0 | — | 0 | 168 |
| 2023 | 0 | — | 0 | 160 |
| 2024 | 0 | — | 0 | 187 |
| 2025 | 0 | — | 0 | 195 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040959 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040959: Mentor Genesis Penile Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040959
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026