510(k) · Decided
DecidedDSS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Spine, LLC · NQP Posterior Metal/Polymer Spinal System, Fusion
Cleared on Jan 24, 2008 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 24, 2008
- Review
- 94 days
- Class
- Class II
- Product code
- NQP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK072969 DSSParadigm Spine, LLC · 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) | K072969 | DSS | Paradigm Spine, LLC | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 | — |
https://510kreport.com/device/K072969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072969: DSS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072969
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026