510(k) · Decided
Recalled · Class II · 2012Dynesys Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centerpulse Spine-Tech, Inc. · NQP Posterior Metal/Polymer Spinal System, Fusion
Cleared on Mar 5, 2004 as substantially equivalent to K980288 (Spine-Tech, Inc., 1998) after a 296-day review. Its family tree reaches back 1 generation to 1998. 1 of the 904 devices in its family, counting itself, has a Class I recall. 902 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 5, 2004
- Review
- 296 days
- Class
- Class II
- Product code
- NQP
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980288 (1998). 902 later devices descend from it, 8 citing it directly. 1 of the 904 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- This deviceK031511 Dynesys Spinal SystemCenterpulse Spine-Tech, Inc. · 2004
- Descendant · cites it directly · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · cites it directly · 834 of its ownK043565 Modification to Dynesys Spinal SystemZimmer Spine, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 822 of its ownK060615 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · Recalled
- Descendant · 2 generations on · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 780 of its ownK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
Showing 5 of 902 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 902 · See all- K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · cites it directly870descendants
- K043565Modification to Dynesys Spinal SystemZimmer Spine, Inc. · 2005 · cites it directly834descendants
- K060615CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · 2 generations on822descendants
- K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 2 generations on821descendants
- K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on780descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| 0 (this device) | K031511 | Dynesys Spinal System | Centerpulse Spine-Tech, Inc. | 2004 | — |
| +1 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +1 | K043565 | Modification to Dynesys Spinal System | Zimmer Spine, Inc. | 2005 | 1 |
| +2 | K060615 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | 34 |
| +2 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 27 | 0 |
| 2013 | 41 | 0 |
| 2014 | 44 | 0 |
| 2015 | 47 | 0 |
| 2016 | 48 | 0 |
| 2017 | 49 | 0 |
| 2018 | 54 | 0 |
| 2019 | 46 | 0 |
| 2020 | 63 | 0 |
| 2021 | 57 | 1 |
| 2022 | 69 | 0 |
| 2023 | 88 | 0 |
| 2024 | 79 | 0 |
| 2025 | 73 | 0 |
| 2026 | 66 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K980288 | Spine-Tech Silhouette Spinal Fixation SystemSummary page 1…70) Panel -Orthopedic Predicate Device: SilhouetteTM Spinal Fixation System (K980288) Subject Device Description: The DYNESYS®k Spinal 'Systemn consists of four pedicle screws, two cords and two spacers in a symm… | 1998 |
What descends from it? (902)
See all 9028 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050809 | CD Horizon Spinal System | 2005 | 870 |
| K043565 | Modification to Dynesys Spinal System | 2005 | 834 |
| K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | 2006 | 131 |
| K060638 | Dynesys Spinal System with HA Coated Screws | 2006 | 13 |
| K073439 | Transition Stabilization System | 2009 | 2 |
| K061774 | Nfix II Pedicle Screw System | 2006 | 2 |
| K071879 | Zimmer Dto Implant | 2007 | 1 |
| K073143 | Modified Vertiflex Spinal Screw System | 2008 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0236-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0237-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0239-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0238-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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.
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?
When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal System 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…
Read the full statement (124 words)
When used as a pedicle screw fixation system in skeletally mature patients, the
DYNESYS Spinal System 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, when used as a pedicle screw fixation system, the DYNESYS Spinal System
is indicated for use in patients:
a) Who are receiving fusions with autogenous graft only
b) Who are having the device fixed or attached to the lumbar or sacral spine; and
c) Who are having the device removed after the development of a solid fusion
mass.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031511: Dynesys Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031511
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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