510(k) · Decided
DecidedModification to: DSS Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 20, 2009 as substantially equivalent to K080241 (Paradigm Spine, LLC, 2008) after a 30-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it.
- Decided
- Mar 20, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901587 (1990). 22 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 1 generation backK080241 DDS Stabilization SystemParadigm Spine, LLC · 2008
- This deviceK090408 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
- Descendant · cites it directly · 3 of its ownK091944 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
- Descendant · cites it directly · 2 of its ownK101083 DSS Stabilization SystemParadigm Spine, LLC · 2010
- Descendant · cites it directly · 1 of its ownK113625 DSS Stabilization SystemParadigm Spine, LLC · 2012
- Descendant · cites it directly · 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 · cites it directly2descendants
- K113625DSS Stabilization SystemParadigm Spine, LLC · 2012 · cites it directly1descendant
- K120491DSS Stabilization System-RigidParadigm Spine, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −3 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −2 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K080241 | DDS Stabilization System | Paradigm Spine, LLC | 2008 | — |
| 0 (this device) | K090408 | Modification to: DSS Stabilization System | Paradigm Spine, LLC | 2009 | — |
| +1 | K091944 | Modification to: DSS Stabilization System | Paradigm Spine, LLC | 2009 | — |
| +1 | K101083 | DSS Stabilization System | Paradigm Spine, LLC | 2010 | — |
| +1 | K113625 | DSS Stabilization System | Paradigm Spine, LLC | 2012 | — |
| +1 | K120491 | DSS Stabilization System-Rigid | Paradigm Spine, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080241 | DDS Stabilization SystemSummary page 1…from medical grade titanium alloy (Ti6A14V). Predicate Device(s): DSSTM Stabilization System was shown to be substantially equivalent to previously cleared devices (K080241) and has the same indications for use, design, function,·and materials used. Performance Standards: Testing performed indicat… | 2008 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K091944 (Paradigm Spine, LLC, 2009) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K080241.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The DSS Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis…
Read the full statement (101 words)
The DSS Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS Stabilization System - Rigid Coupler is intended to be used with autograft and/or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090408: Modification to: 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/K090408
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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