# P140004: Superion Interspinous Spacer

- Pathway: PMA
- Applicant: Boston Scientific Neuromodulation
- Decided: May 20, 2015 after 415 days
- Product code: NQO (Prosthesis, Spinous Process Spacer/Plate)
- Device class: 3
- Recalls of this device: 3 (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
- Jun 6, 2025 · Class II · Z-2485-2025: As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the inst
- May 12, 2023 · Class II · Z-1972-2023: Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal
- Oct 12, 2022 · Class II · Z-0230-2023: Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it 

Source page: https://510kreport.com/device/P140004
Methodology: https://510kreport.com/methodology