510(k) · Decided
DecidedDSS Stabilization System-Rigid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Spine, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 9, 2012 as substantially equivalent to K042962 (Medtronic Sofamor Danek, 2004) and 5 other predicates after an 82-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- May 9, 2012
- Review
- 82 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K901587 (1990). 42 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 7 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 6 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 5 generations backK080241 DDS Stabilization SystemParadigm Spine, LLC · 2008
- 4 generations backK090408 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
- 3 generations backK091944 Modification to: DSS Stabilization SystemParadigm Spine, LLC · 2009
- 2 generations backK101083 DSS Stabilization SystemParadigm Spine, LLC · 2010
- 1 generation backK113625 DSS Stabilization SystemParadigm Spine, LLC · 2012
- This deviceK120491 DSS Stabilization System-RigidParadigm Spine, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −7 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −6 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −5 | K080241 | DDS Stabilization System | Paradigm Spine, LLC | 2008 | — |
| −4 | K090408 | Modification to: DSS Stabilization System | Paradigm Spine, LLC | 2009 | — |
| −3 | K091944 | Modification to: DSS Stabilization System | Paradigm Spine, LLC | 2009 | — |
| −2 | K101083 | DSS Stabilization System | Paradigm Spine, LLC | 2010 | — |
| −1 | K113625 | DSS Stabilization System | Paradigm Spine, LLC | 2012 | — |
| 0 (this device) | 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 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K042962 | Modification to CD Horizon Spinal SystemSummary page 2…the DSSTM Stabilization System - Rigid. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K042962, K080241, K090099, K090408, K101083, and K 113625) and has the same indications for use, design, function, and materials used. S… | 2004 |
| * | K080241 | DDS Stabilization SystemSummary page 2…M Stabilization System - Rigid. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K042962, K080241, K090099, K090408, K101083, and K 113625) and has the same indications for use, design, function, and materials used. Substantia… | 2008 |
| * | K090099 | DSS Stabilization SystemSummary page 2…zation System - Rigid. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K042962, K080241, K090099, K090408, K101083, and K 113625) and has the same indications for use, design, function, and materials used. Substantial Equival… | 2009 |
| * | K090408 | Modification to: DSS Stabilization SystemSummary page 2…stem - Rigid. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K042962, K080241, K090099, K090408, K101083, and K 113625) and has the same indications for use, design, function, and materials used. Substantial Equivalence: Pre… | 2009 |
| * | K101083 | DSS Stabilization SystemSummary page 2…gid. Predicate Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K042962, K080241, K090099, K090408, K101083, and K 113625) and has the same indications for use, design, function, and materials used. Substantial Equivalence: Previous per… | 2010 |
| * | K113625 | DSS Stabilization SystemSummary page 2…te Device(s): DSSTM Stabilization System - Rigid was shown to be substantially equivalent to previously cleared devices (K042962, K080241, K090099, K090408, K101083, and K 113625) and has the same indications for use, design, function, and materials used. Substantial Equivalence: Previous performance testi… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 42 ancestors have a recall of any class.
- 9 other devices also cite its predicate K042962.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DSSTM Stabilization System - Rigid The DSSTM Stabilization System - Rigid is intended 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)…
Read the full statement (246 words)
DSSTM Stabilization System - Rigid
The DSSTM Stabilization System - Rigid is intended 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 DSSTM Stabilization System - Rigid is intended to be used with autograft and/or allograft.
Note: The Rigid Couplers are for single-level use only. The traditional straight rods are for single- and multi-level use.
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/K120491 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120491: DSS Stabilization System-Rigid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120491
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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