510(k) · Cleared
Recalled · Class II · 2012Dynesys Spinal System with HA Coated Screws
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 Apr 6, 2006 as substantially equivalent to K031511 (Centerpulse Spine-Tech, Inc., 2004) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1998. 13 later devices descend from it. It has been recalled once.
- Decided
- Apr 6, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- NQP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980288 (1998). 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- 2 generations backK031511 Dynesys Spinal SystemCenterpulse Spine-Tech, Inc. · 2004 · Recalled
- 1 generation backK043565 Modification to Dynesys Spinal SystemZimmer Spine, Inc. · 2005 · Recalled
- This deviceK060638 Dynesys Spinal System with HA Coated ScrewsZimmer Spine, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK101790 Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
- Descendant · 2 generations on · 7 of its ownK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 6 of its ownK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
- Descendant · 4 generations on · 5 of its ownK140696 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK192800 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011 · cites it directly10descendants
- K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · 2 generations on7descendants
- K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013 · 3 generations on6descendants
- K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014 · 4 generations on5descendants
- K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| −2 | K031511 | Dynesys Spinal System | Centerpulse Spine-Tech, Inc. | 2004 | 4 |
| −1 | K043565 | Modification to Dynesys Spinal System | Zimmer Spine, Inc. | 2005 | 1 |
| 0 (this device) | K060638 | Dynesys Spinal System with HA Coated Screws | Zimmer Spine, Inc. | 2006 | — |
| +1 | K101790 | Quantum Spinal System, Quantum Mis | Pioneer Surgical Technology | 2011 | — |
| +2 | K130286 | Streamline Mis Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2013 | 1 |
| +3 | K131100 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2013 | — |
| +4 | K140696 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2014 | — |
| +2 | K192800 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (2)
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 SystemSummary page 1…al system Class: 1I Product Code: NQP Predicate Devices: Dynesys® Spinal System (K03151 1, K043565) Description of Device: The Dynesys Spinal System is comprised of a variety pedicle screws… | 2004 |
| * | K043565 | Modification to Dynesys Spinal SystemSummary page 1…Class: 1I Product Code: NQP Predicate Devices: Dynesys® Spinal System (K03151 1, K043565) Description of Device: The Dynesys Spinal System is comprised of a variety pedicle screws sizes, t… | 2005 |
What descends from it? (13)
See all 132 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0240-2013 | 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 Winterthru, Switzerland, after receiving four complaints of a discrepancy between product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K101790 (Pioneer Surgical Technology, 2011) has gone furthest, with 10 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/K060638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060638: Dynesys Spinal System with HA Coated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060638
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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