510(k) · Cleared
ClearedDSS Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Spine · NQP Posterior Metal/Polymer Spinal System, Fusion
Cleared on May 2, 2008 after a 28-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- May 2, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- NQP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK080963 DSS Stabilization SystemParadigm Spine · 2008
- Descendant · cites it directly · 3 of its ownK091944 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
- Descendant · 2 generations on · 2 of its ownK101083 DSS Stabilization SystemParadigm Spine, LLC · 2010
- Descendant · 3 generations on · 1 of its ownK113625 DSS Stabilization SystemParadigm Spine, LLC · 2012
- Descendant · 3 generations on · 0 of its ownK120491 DSS Stabilization System-RigidParadigm Spine, LLC · 2012
Most influential descendants
Showing 4 of 4 · See all- K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009 · cites it directly3descendants
- K101083DSS Stabilization SystemParadigm Spine, LLC · 2010 · 2 generations on2descendants
- K113625DSS Stabilization SystemParadigm Spine, LLC · 2012 · 3 generations on1descendant
- K120491DSS Stabilization System-RigidParadigm Spine, LLC · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080963 | DSS Stabilization System | Paradigm Spine | 2008 | — |
| +1 | K091944 | Modification to: DSS Stabilization System | Paradigm Spine, LLC | 2009 | — |
| +2 | K101083 | DSS Stabilization System | Paradigm Spine, LLC | 2010 | — |
| +3 | K113625 | DSS Stabilization System | Paradigm Spine, LLC | 2012 | — |
| +3 | K120491 | DSS Stabilization System-Rigid | Paradigm Spine, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NQP device
- #1 K203678 CD HORIZON™ Spinal Systemscore 10.9 · 15 generations · no Class I recall
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091944 | Modification to: DSS Stabilization System | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091944 (Paradigm Spine, LLC, 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NQP devicesNQP Posterior Metal/Polymer Spinal System, Fusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NQP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NQP
70in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQP
6in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQP
8in 2025
MAUDE reports naming product code NQP, 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 | 2 | — | 34 | 45 |
| 2008 | 6 | 156 | 4 | 101 |
| 2009 | 3 | 70 | 6 | 109 |
| 2010 | 2 | — | 0 | 119 |
| 2011 | 0 | — | 0 | 60 |
| 2012 | 0 | — | 6 | 66 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 1 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 79 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DSSTM Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis).
In addition, the DSSTM Stabilization System is indicated for use in patients:
* Who are receiving fusions with autogenous graft only;
* Who are having the device fixed or attached to the lumbar or sacral spine;
* Who are having the device removed after the development of a solid fusion mass.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080963: DSS Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080963
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026