PMA · Approved
Recalled · 2008X Stop Interspinous Process Decompression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · NQO Prosthesis, Spinous Process Spacer/Plate
Approved on Nov 21, 2005 through premarket approval, which rests on the device’s own clinical evidence after a 685-day review. It has been recalled 2 times.
- Decided
- Nov 21, 2005
- Review
- 685 days
- Class
- Class III
- Product code
- NQO
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040001 has 19 supplements since 2006: 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 |
|---|---|
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 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.
Planning a device in NQO? 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2008 | Not classified | Z-1765-2008 | Labeling design | 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 universal wing assembly. This includes… |
| Jun 6, 2006 | Not classified | Z-1258-06 | Other | Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All NQO devicesNQO Prosthesis, Spinous Process Spacer/Plate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQO
Too few NQO 510(k)s in any year since 2007 to give a median.
Recalls per year · NQO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQO
759in 2025
MAUDE reports naming product code NQO, 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 | 3 | — | 0 | 19 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | — | 0 | 205 |
| 2010 | 3 | — | 0 | 127 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 32 |
| 2013 | 2 | — | 0 | 64 |
| 2014 | 2 | — | 0 | 42 |
| 2015 | 5 | — | 0 | 33 |
| 2016 | 4 | — | 0 | 31 |
| 2017 | 5 | — | 0 | 34 |
| 2018 | 9 | — | 0 | 17 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 10 | — | 0 | 206 |
| 2021 | 3 | — | 0 | 474 |
| 2022 | 2 | — | 1 | 345 |
| 2023 | 2 | — | 0 | 250 |
| 2024 | 3 | — | 0 | 159 |
| 2025 | 1 | — | 0 | 759 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P040001 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040001: X Stop Interspinous Process Decompression System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040001
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026