510(k) · Cleared
ClearedMerlin Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 31, 2004 after a 105-day review. The FDA summary names no predicate by number. 1 of the 738 devices in its family, counting itself, has a Class I recall. 737 later devices descend from it.
- Decided
- Mar 31, 2004
- Review
- 105 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
737 later devices descend from it, 35 citing it directly. 1 of the 738 devices in this family, counting this one, has a Class I recall.
- This deviceK033901 Merlin Spine SystemDepuy Spine, Inc. · 2004
- Descendant · cites it directly · 640 of its ownK041119 Expedium Spine SystemDepuy Spine, Inc. · 2004
- Descendant · cites it directly · 539 of its ownK071495 Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007
- Descendant · cites it directly · 538 of its ownK073364 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
- Descendant · cites it directly · 533 of its ownK041801 Expedium Mis Spine SystemDepuy Spine, Inc. · 2004
- Descendant · cites it directly · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
Showing 5 of 737 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 737 · See all- K041119Expedium Spine SystemDepuy Spine, Inc. · 2004 · cites it directly640descendants
- K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007 · cites it directly539descendants
- K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008 · cites it directly538descendants
- K041801Expedium Mis Spine SystemDepuy Spine, Inc. · 2004 · cites it directly533descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · cites it directly518descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033901 | Merlin Spine System | Depuy Spine, Inc. | 2004 | — |
| +1 | K041119 | Expedium Spine System | Depuy Spine, Inc. | 2004 | — |
| +1 | K071495 | Expedium 4.5MM Spine System | Depuy Spine, A Johnson & Johnson Company | 2007 | — |
| +1 | K073364 | Expedium 4.5MM Spine System | Depuy Spine, Inc. | 2008 | — |
| +1 | K041801 | Expedium Mis Spine System | Depuy Spine, Inc. | 2004 | — |
| +1 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 9 | 0 |
| 2010 | 13 | 0 |
| 2011 | 20 | 0 |
| 2012 | 40 | 0 |
| 2013 | 36 | 0 |
| 2014 | 33 | 0 |
| 2015 | 39 | 0 |
| 2016 | 36 | 0 |
| 2017 | 48 | 0 |
| 2018 | 45 | 0 |
| 2019 | 42 | 0 |
| 2020 | 47 | 0 |
| 2021 | 32 | 1 |
| 2022 | 42 | 0 |
| 2023 | 68 | 0 |
| 2024 | 58 | 0 |
| 2025 | 50 | 0 |
| 2026 | 50 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (737)
See all 73735 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041119 | Expedium Spine System | 2004 | 640 |
| K071495 | Expedium 4.5MM Spine System | 2007 | 539 |
| K073364 | Expedium 4.5MM Spine System | 2008 | 538 |
| K041801 | Expedium Mis Spine System | 2004 | 533 |
| K082942 | Modfication to: Expedium Spine System | 2008 | 518 |
| K052131 | Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods | 2005 | 495 |
| K051024 | Expedium Spine System | 2005 | 493 |
| K062174 | Modification to Expedium Spine System | 2006 | 490 |
| K090230 | Expedium Spine System | 2009 | 462 |
| K071860 | Modification to: Viper Spine System | 2007 | 423 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K041119 (Depuy Spine, Inc., 2004) has gone furthest, with 640 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.
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 Merlin Spinal System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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 in skeletally mature patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033901: Merlin Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033901
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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