510(k) · Cleared
Recalled · Class III · 2015Mercury 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 Oct 12, 2007 after a 93-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it. It has been recalled 22 times.
- Decided
- Oct 12, 2007
- Review
- 93 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 22
- Predicates
- 0
13 later devices descend from it, 6 citing it directly.
- This deviceK071914 Mercury Spinal SystemSpinal Elements, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK082353 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 11 of its ownK083230 Mercury Spinal SystemSpinal Elements, Inc. · 2008
- 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
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K082353Mercury Spinal SystemSpinal Elements, Inc. · 2009 · cites it directly11descendants
- K083230Mercury Spinal SystemSpinal Elements, Inc. · 2008 · cites it directly11descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071914 | Mercury Spinal System | Spinal Elements, Inc. | 2007 | — |
| +1 | K082353 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +1 | K083230 | Mercury Spinal System | Spinal Elements, Inc. | 2008 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 136 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 |
|---|---|---|---|---|
| Apr 9, 2015 | Class III | Z-1597-2015 | Under Investigation by firm | Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of… |
| Apr 17, 2009 | Class III | Z-1266-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1260-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1261-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1248-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1249-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1251-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1256-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1250-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1265-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1247-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1262-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1264-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1253-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1246-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1263-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1252-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1258-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1259-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1254-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1257-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
| Apr 17, 2009 | Class III | Z-1255-2013 | Nonconforming Material/Component | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. |
The 5 latest of 22 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082353 (Spinal Elements, Inc., 2009) has gone furthest, with 11 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 510(k) statement.
https://510kreport.com/device/K071914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071914: Mercury 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/K071914
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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