510(k) · Decided
DecidedDDS Stabilization System
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 Nov 28, 2008 as substantially equivalent to K962628 (Depuy, Inc., 1997) and 3 other predicates after a 302-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- Nov 28, 2008
- Review
- 302 days
- Class
- Class II
- Product code
- NQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K901587 (1990). 21 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 2 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 1 generation backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- This deviceK080241 DDS Stabilization SystemParadigm Spine, LLC · 2008
- Descendant · cites it directly · 4 of its ownK090408 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 5 of 5 · See all- K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −2 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −1 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| 0 (this device) | K080241 | DDS Stabilization System | Paradigm Spine, LLC | 2008 | — |
| +1 | 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 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K962628 | Moss Miami Spinal SystemSummary page 2…ent to previously cleared devices and has the same indications for use, design, function, and materials used, including, but not limited to: 1. DePuy MOSS Miami (K962628) 2. Biomet Synergy VLS Open (K973836) 3. Synthes Pangea (K052123) 4. Zimmer Silhouette (K993067) Performanc… | 1997 |
| * | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Summary page 2…e same indications for use, design, function, and materials used, including, but not limited to: 1. DePuy MOSS Miami (K962628) 2. Biomet Synergy VLS Open (K973836) 3. Synthes Pangea (K052123) 4. Zimmer Silhouette (K993067) Performance Standards: Testing performed indicates the… | 1998 |
| * | K052123 | Synthes Pangea SystemSummary page 2…function, and materials used, including, but not limited to: 1. DePuy MOSS Miami (K962628) 2. Biomet Synergy VLS Open (K973836) 3. Synthes Pangea (K052123) 4. Zimmer Silhouette (K993067) Performance Standards: Testing performed indicates the DSSTM Stabilization System is subs… | 2005 |
| * | K993067 | Silhouette Spinal Fixation SystemSummary page 2…ng, but not limited to: 1. DePuy MOSS Miami (K962628) 2. Biomet Synergy VLS Open (K973836) 3. Synthes Pangea (K052123) 4. Zimmer Silhouette (K993067) Performance Standards: Testing performed indicates the DSSTM Stabilization System is substantially equivalent to predicate devi… | 1999 |
What descends from it? (5)
5 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 18 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K090408 (Paradigm Spine, LLC, 2009) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K962628.
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 DSS Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to SI 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 (100 words)
The DSS Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to SI 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 is intended to be used with autograft and/or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080241 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080241: DDS Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080241
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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