# P850022: Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy

- Pathway: PMA
- Applicant: Ahp Eos Buyer, Inc.
- Decided: Feb 18, 1986 after 313 days
- Product code: LOF (Stimulator, Bone Growth, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 890.5870
- Recalls of this device: 4 (0 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.
0 of 1 device in its family (counting itself) have 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
- Mar 22, 2024 · Class II · Z-1619-2024: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of 
- Mar 22, 2024 · Class II · Z-1618-2024: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of 
- Mar 22, 2024 · Class II · Z-1616-2024: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of 
- Mar 22, 2024 · Class II · Z-1617-2024: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of 

Source page: https://510kreport.com/device/P850022
Methodology: https://510kreport.com/methodology