510(k) · Cleared
ClearedModification to: DSS 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 Aug 3, 2009 as substantially equivalent to K072969 (Paradigm Spine, LLC, 2008) and 4 other predicates after a 34-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it.
- Decided
- Aug 3, 2009
- Review
- 34 days
- Class
- Class II
- Product code
- NQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K901587 (1990). 26 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK080241 DDS Stabilization SystemParadigm Spine, LLC · 2008
- 1 generation backK090408 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
- This deviceK091944 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
- Descendant · cites it directly · 2 of its ownK101083 DSS Stabilization SystemParadigm Spine, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK113625 DSS Stabilization SystemParadigm Spine, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK120491 DSS Stabilization System-RigidParadigm Spine, LLC · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K080241 | DDS Stabilization System | Paradigm Spine, LLC | 2008 | — |
| −1 | K090408 | Modification to: DSS Stabilization System | Paradigm Spine, LLC | 2009 | — |
| 0 (this device) | K091944 | Modification to: DSS Stabilization System | Paradigm Spine, LLC | 2009 | — |
| +1 | K101083 | DSS Stabilization System | Paradigm Spine, LLC | 2010 | — |
| +2 | K113625 | DSS Stabilization System | Paradigm Spine, LLC | 2012 | — |
| +2 | 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 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K072969 | DSSSummary page 2…red from medical grade titanium alloy (Ti6AI4V). Predicate Device(s): DSSTM Stabilization System was shown to be substantially equivalent to previously cleared devices (K072969, K080963, K080241, K090408 and K090099) and has the same indications for use, design, function, and materials used. Performance… | 2008 |
| * | K080963 | DSS Stabilization SystemSummary page 2…medical grade titanium alloy (Ti6AI4V). Predicate Device(s): DSSTM Stabilization System was shown to be substantially equivalent to previously cleared devices (K072969, K080963, K080241, K090408 and K090099) and has the same indications for use, design, function, and materials used. Performance Standards… | 2008 |
| * | K080241 | DDS Stabilization SystemSummary page 2…rade titanium alloy (Ti6AI4V). Predicate Device(s): DSSTM Stabilization System was shown to be substantially equivalent to previously cleared devices (K072969, K080963, K080241, K090408 and K090099) and has the same indications for use, design, function, and materials used. Performance Standards: Testing… | 2008 |
| * | K090408 | Modification to: DSS Stabilization SystemSummary page 2…nium alloy (Ti6AI4V). Predicate Device(s): DSSTM Stabilization System was shown to be substantially equivalent to previously cleared devices (K072969, K080963, K080241, K090408 and K090099) and has the same indications for use, design, function, and materials used. Performance Standards: Testing performe… | 2009 |
| * | K090099 | DSS Stabilization SystemSummary page 2…Ti6AI4V). Predicate Device(s): DSSTM Stabilization System was shown to be substantially equivalent to previously cleared devices (K072969, K080963, K080241, K090408 and K090099) and has the same indications for use, design, function, and materials used. Performance Standards: Testing performed indicate t… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101083 | DSS Stabilization System | 2010 | 2 |
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 1.1 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K101083 (Paradigm Spine, LLC, 2010) has gone furthest, with 2 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. 2009, 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?
DSSTM Stabilization System - Rigid The DSSTM 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…
Read the full statement (228 words)
DSSTM Stabilization System - Rigid
The DSSTM 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 DSSTM Stabilization System - Rigid is intended to be used with autograft and/or allograft.
DSSTM Stabilization System - Slotted
The DSSTM Stabilization System - Slotted 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 - Slotted 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.
Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091944 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091944: Modification to: DSS Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091944
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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