510(k) · Cleared
Recalled · Class II · 2012Modification to Dynesys Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · NQP Posterior Metal/Polymer Spinal System, Fusion
Cleared on Mar 11, 2005 as substantially equivalent to K031511 (Centerpulse Spine-Tech, Inc., 2004) after a 74-day review. Its family tree reaches back 2 generations to 1998. 1 of the 837 devices in its family, counting itself, has a Class I recall. 834 later devices descend from it. It has been recalled once.
- Decided
- Mar 11, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- NQP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980288 (1998). 834 later devices descend from it, 3 citing it directly. 1 of the 837 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- 1 generation backK031511 Dynesys Spinal SystemCenterpulse Spine-Tech, Inc. · 2004 · Recalled
- This deviceK043565 Modification to Dynesys Spinal SystemZimmer Spine, Inc. · 2005
- Descendant · cites it directly · 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 · 3 generations on · 779 of its ownK082236 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · 4 generations on · 776 of its ownK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 4 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
Showing 5 of 834 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 834 · See all- K060615CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · cites it directly822descendants
- K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 2 generations on821descendants
- K082236CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008 · 3 generations on779descendants
- K091442CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · 4 generations on776descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 4 generations on656descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| −1 | K031511 | Dynesys Spinal System | Centerpulse Spine-Tech, Inc. | 2004 | 4 |
| 0 (this device) | K043565 | Modification to Dynesys Spinal System | Zimmer Spine, Inc. | 2005 | — |
| +1 | K060615 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | 34 |
| +2 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +3 | K082236 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +4 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +4 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 21 | 0 |
| 2013 | 35 | 0 |
| 2014 | 39 | 0 |
| 2015 | 41 | 0 |
| 2016 | 42 | 0 |
| 2017 | 46 | 0 |
| 2018 | 54 | 0 |
| 2019 | 45 | 0 |
| 2020 | 61 | 0 |
| 2021 | 56 | 1 |
| 2022 | 69 | 0 |
| 2023 | 86 | 0 |
| 2024 | 77 | 0 |
| 2025 | 71 | 0 |
| 2026 | 65 | 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 |
|---|---|---|---|
| * | K031511 | Dynesys Spinal System | 2004 |
What descends from it? (834)
See all 8343 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-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… |
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K060615 (Medtronic Sofamor Danek, 2006) has gone furthest, with 822 descendants of its own.
- 7 other devices also cite its predicate K031511.
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, and failed previous fusion (pseudarthrosis). In…
Read the full statement (122 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, 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:
* 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043565: Modification to Dynesys Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043565
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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