PMA · Approved
Recalled · Class I · 2018OsteoGenTM Implantable Bone Growth Stimulators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ahp Eos Buyer, Inc. · LOE Stimulator, Invasive Bone Growth
Approved on Jan 25, 1980 through premarket approval, which rests on the device’s own clinical evidence after a 359-day review. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jan 25, 1980
- Review
- 359 days
- Class
- Class III
- Product code
- LOE
- Recalls
- 1 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P790005 has 58 supplements since 1980: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1980 | 1 |
| 1981 | 6 |
| 1982 | 3 |
| 1983 | 5 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 2 |
| 1990 | 3 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 2000 | 2 |
| 2005 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 8 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2018 | Class I | Z-0286-2019 | Under Investigation by firm | Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LOE devicesLOE Stimulator, Invasive Bone Growth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOE
Too few LOE 510(k)s in any year since 2007 to give a median.
Recalls per year · LOE
2in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LOE
7in 2025
MAUDE reports naming product code LOE, 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 | 1 | — | 0 | 2 |
| 2008 | 3 | — | 0 | 32 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 4 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 4 | — | 0 | 6 |
| 2016 | 4 | — | 0 | 5 |
| 2017 | 4 | — | 0 | 5 |
| 2018 | 16 | — | 2 (2) | 8 |
| 2019 | 4 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 4 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P790005 · printed Nov 6, 2026
Cite this page
510(k) Report. “P790005: OsteoGenTM Implantable Bone Growth Stimulators.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P790005
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026