# P040001: X Stop Interspinous Process Decompression System

- Pathway: PMA
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Nov 21, 2005 after 685 days
- Product code: NQO (Prosthesis, Spinous Process Spacer/Plate)
- Device class: 3
- Recalls of this device: 2 (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
- Jan 30, 2008 · Not classified · Z-1765-2008: Physician instructions revised due to product breakage: During the implantation of the X-STOP IPD Device, the product has the potential to cause damage to and/or breakage of the X-STOP IPD Device's un
- Jun 6, 2006 · Not classified · Z-1258-06: Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.

Source page: https://510kreport.com/device/P040001
Methodology: https://510kreport.com/methodology