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 Aug 22, 2014 as substantially equivalent to K071914 (Spinal Elements, Inc., 2007) and 5 other predicates after an 87-day review. Its family tree reaches back 8 generations to 2004. 9 later devices descend from it.
- Decided
- Aug 22, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K040583 (2004). 79 ancestors in all, the oldest K841189 (1984). 9 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 5 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 3 generations backK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- 2 generations backK083230 Mercury Spinal SystemSpinal Elements, Inc. · 2008
- 1 generation backK091587 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- This deviceK141372 Mercury Spinal SystemSpinal Elements, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK151215 Mercury Spinal SystemSpinal Elements, Inc. · 2015
- Descendant · cites it directly · 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
- Descendant · cites it directly · 3 of its ownK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151215Mercury Spinal SystemSpinal Elements, Inc. · 2015 · cites it directly8descendants
- K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019 · cites it directly5descendants
- K172967Mercury® Spinal SystemSpinal Elements, Inc. · 2018 · cites it directly5descendants
- K222516Mercury® II Spinal SystemSpinal Elements, Inc. · 2022 · cites it directly3descendants
- K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −5 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −3 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| −2 | K083230 | Mercury Spinal System | Spinal Elements, Inc. | 2008 | — |
| −1 | K091587 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| 0 (this device) | K141372 | Mercury Spinal System | Spinal Elements, Inc. | 2014 | — |
| +1 | K151215 | Mercury Spinal System | Spinal Elements, Inc. | 2015 | — |
| +1 | K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | 2019 | — |
| +1 | K172967 | Mercury® Spinal System | Spinal Elements, Inc. | 2018 | — |
| +1 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | — |
| +2 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | — |
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 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 4…NKB, MNI, MNH, KWP, KWQ Purpose of this 510(k) This 510(k) seeks clearance for line additions to the Mercury® Spinal System previously cleared for use under K071914, K082353, K083230, and K091587. Additionally, the Indications for Use are being modified. Device Description Spinal Elements’ M… | 2007 |
| * | K083230 | Mercury Spinal SystemSummary page 4…I, MNH, KWP, KWQ Purpose of this 510(k) This 510(k) seeks clearance for line additions to the Mercury® Spinal System previously cleared for use under K071914, K082353, K083230, and K091587. Additionally, the Indications for Use are being modified. Device Description Spinal Elements’ Mercury Spinal Syst… | 2008 |
| * | K082353 | Mercury Spinal SystemSummary page 4…NKB, MNI, MNH, KWP, KWQ Purpose of this 510(k) This 510(k) seeks clearance for line additions to the Mercury® Spinal System previously cleared for use under K071914, K082353, K083230, and K091587. Additionally, the Indications for Use are being modified. Device Description Spinal Elements’ Mercury Sp… | 2009 |
| * | K091587 | Mercury Spinal SystemSummary page 4…KWQ Purpose of this 510(k) This 510(k) seeks clearance for line additions to the Mercury® Spinal System previously cleared for use under K071914, K082353, K083230, and K091587. Additionally, the Indications for Use are being modified. Device Description Spinal Elements’ Mercury Spinal System is compris… | 2009 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 5…ollowing predicate devices: • Spinal Elements’ Mercury Spinal System (K071914, K083230, K082353, and K091587) • Depuy Acromed’s Mossi Miami Spinal System (K030383) • Synthes’ USS Iliosacral System (K082572) Performance Data Performance testing included: • Static Axial Grip and Tors… | 2003 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 5…ts’ Mercury Spinal System (K071914, K083230, K082353, and K091587) • Depuy Acromed’s Mossi Miami Spinal System (K030383) • Synthes’ USS Iliosacral System (K082572) Performance Data Performance testing included: • Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1… | 2008 |
What descends from it? (9)
4 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 10 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 8 of the 79 ancestors have a recall of any class.
- Of its descendants, K151215 (Spinal Elements, Inc., 2015) has gone furthest, with 8 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. 2014, 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 to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is intended for anterior/anterolateral nonpedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following…
Read the full statement (120 words)
The Mercury® Spinal System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is intended for anterior/anterolateral nonpedicle 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.
This system is intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141372: 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/K141372
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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