# P790005: OsteoGenTM Implantable Bone Growth Stimulators

- Pathway: PMA
- Applicant: Ahp Eos Buyer, Inc.
- Decided: Jan 25, 1980 after 359 days
- Product code: LOE (Stimulator, Invasive Bone Growth)
- Device class: 3
- Recalls of this device: 1 (1 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 19, 2018 · Class I · Z-0286-2019: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

Source page: https://510kreport.com/device/P790005
Methodology: https://510kreport.com/methodology