510(k) · Cleared
ClearedMercury Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 22, 2009 as substantially equivalent to K071914 (Spinal Elements, Inc., 2007) and 5 other predicates after a 160-day review. Its family tree reaches back 6 generations to 2004. 11 later devices descend from it.
- Decided
- Jan 22, 2009
- Review
- 160 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K040583 (2004). 65 ancestors in all, the oldest K841189 (1984). 11 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 3 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 1 generation backK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- This deviceK082353 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK091587 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK141372 Mercury Spinal SystemSpinal Elements, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK151215 Mercury Spinal SystemSpinal Elements, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK191576 Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK172967 Mercury® Spinal SystemSpinal Elements, Inc. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K091587Mercury Spinal SystemSpinal Elements, Inc. · 2009 · cites it directly10descendants
- K141372Mercury Spinal SystemSpinal Elements, Inc. · 2014 · cites it directly9descendants
- K151215Mercury Spinal SystemSpinal Elements, Inc. · 2015 · cites it directly8descendants
- K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019 · 2 generations on5descendants
- K172967Mercury® Spinal SystemSpinal Elements, Inc. · 2018 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −3 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −1 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| 0 (this device) | K082353 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +1 | K091587 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +1 | K141372 | Mercury Spinal System | Spinal Elements, Inc. | 2014 | — |
| +1 | K151215 | Mercury Spinal System | Spinal Elements, Inc. | 2015 | — |
| +2 | K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | 2019 | — |
| +1 | K172967 | Mercury® Spinal System | Spinal Elements, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K071914 | Mercury Spinal SystemSummary page 2…The Mercury Spinal System was shown to be substantially equivalent through comparison to the following predicate spinal systems Mercury Spinal System by Spinal Elements (K071914), CD Horizon® Spinal System by Medttronic Sofamor Danek (K063670), Moss Miami Spinal System by DePuy Acromed (K030383), XIA®/XIA®… | 2007 |
| * | K063670 | Modifications to CD Horizon Spinal SystemSummary page 2…t through comparison to the following predicate spinal systems Mercury Spinal System by Spinal Elements (K071914), CD Horizon® Spinal System by Medttronic Sofamor Danek (K063670), Moss Miami Spinal System by DePuy Acromed (K030383), XIA®/XIA® 4 5 Spinal Systems by Stryker Spine (K061854), Omega2lTM Degener… | 2007 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 2…l systems Mercury Spinal System by Spinal Elements (K071914), CD Horizon® Spinal System by Medttronic Sofamor Danek (K063670), Moss Miami Spinal System by DePuy Acromed (K030383), XIA®/XIA® 4 5 Spinal Systems by Stryker Spine (K061854), Omega2lTM Degenerative Spine System by EBI Spine (K031354), and USS by… | 2003 |
| * | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemSummary page 2…14), CD Horizon® Spinal System by Medttronic Sofamor Danek (K063670), Moss Miami Spinal System by DePuy Acromed (K030383), XIA®/XIA® 4 5 Spinal Systems by Stryker Spine (K061854), Omega2lTM Degenerative Spine System by EBI Spine (K031354), and USS by Synthes (K000450) Performance Data Mechanical testing i… | 2006 |
| * | K031354 | Ebi OMEGA21 Spinal Fixation SystemSummary page 2…K063670), Moss Miami Spinal System by DePuy Acromed (K030383), XIA®/XIA® 4 5 Spinal Systems by Stryker Spine (K061854), Omega2lTM Degenerative Spine System by EBI Spine (K031354), and USS by Synthes (K000450) Performance Data Mechanical testing indicates that Mercury Spinal System devices are capable of p… | 2003 |
| * | K000450 | Modification to Synthes UssSummary page 2…stem by DePuy Acromed (K030383), XIA®/XIA® 4 5 Spinal Systems by Stryker Spine (K061854), Omega2lTM Degenerative Spine System by EBI Spine (K031354), and USS by Synthes (K000450) Performance Data Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with t… | 2000 |
What descends from it? (11)
See all 114 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)
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 5 years and passes through 4 companies; a new generation was cleared every 5 months on median.
- 7 of the 65 ancestors have a recall of any class.
- Of its descendants, K091587 (Spinal Elements, Inc., 2009) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K071914.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (Ti-Si) of skeletally mature patients. This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications degenerative disc disease (DDD) (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, pseudoarthrosis, and failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082353: Mercury 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/K082353
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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