PMA · Approved
Recalled · Class II · 2025Superion Interspinous Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Neuromodulation · NQO Prosthesis, Spinous Process Spacer/Plate
Approved on May 20, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 415-day review. It has been recalled 3 times.
- Decided
- May 20, 2015
- Review
- 415 days
- Class
- Class III
- Product code
- NQO
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P140004 has 33 supplements since 2015: 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 |
|---|---|
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 8 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 3 |
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 |
|---|---|---|---|---|
| Jun 6, 2025 | Class II | Z-2485-2025 | Device Design | 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 instruments and implant/device. |
| May 12, 2023 | Class II | Z-1972-2023 | Labeling design | 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 fragments (Driver teeth/tips) within… |
| Oct 12, 2022 | Class II | Z-0230-2023 | Process change control | 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 may prevent proper deployment of the… |
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. 2015, this device’s year, is highlighted.
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/P140004 · printed Nov 6, 2026
Cite this page
510(k) Report. “P140004: Superion Interspinous Spacer.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P140004
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026