510(k) · Cleared
ClearedDuet™ Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Duet Spine Holdings, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 30, 2026 as substantially equivalent to K253169 (Box Spine, LLC, 2026) after a 61-day review. Its family tree reaches back 14 generations to 1999.
- Decided
- Sep 30, 2026
- Review
- 61 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K990745 (1999). 116 ancestors in all, the oldest K884263 (1988). No later device cites it as a predicate yet.
- Root · 14 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations between
- 3 generations backK171838 TiLock2 Spinal SystemGenesys Spine · 2017
- 2 generations backK201427 Trivergent Spinal Fixation SystemBenvenue Medical, Inc. · 2020
- 1 generation backK253169 Duet™ Spinal Fixation SystemBox Spine, LLC · 2026
- This deviceK262712 Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
Show all 14 generations
- Root · 14 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 13 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 12 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 11 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 10 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 9 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 8 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 7 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 6 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 5 generations backK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
- 4 generations backK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
- 3 generations backK171838 TiLock2 Spinal SystemGenesys Spine · 2017
- 2 generations backK201427 Trivergent Spinal Fixation SystemBenvenue Medical, Inc. · 2020
- 1 generation backK253169 Duet™ Spinal Fixation SystemBox Spine, LLC · 2026
- This deviceK262712 Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −13 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −12 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −11 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −10 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −9 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −8 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −7 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −6 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −5 | K103671 | Genesys Spine Tilock System | Genesys Spine | 2011 | — |
| −4 | K152039 | Genesys Spine TiLock2 Spinal System | Genesys Spine | 2015 | — |
| −3 | K171838 | TiLock2 Spinal System | Genesys Spine | 2017 | — |
| −2 | K201427 | Trivergent Spinal Fixation System | Benvenue Medical, Inc. | 2020 | — |
| −1 | K253169 | Duet™ Spinal Fixation System | Box Spine, LLC | 2026 | — |
| 0 (this device) | K262712 | Duet™ Spinal Fixation System | Duet Spine Holdings, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K253169 | Duet™ Spinal Fixation SystemSummary page 5…• Structural support mechanism Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Product Code Predicate Type K253169 Duet™ Spinal Fixation System Box Spine, LLC NKB Primary 1|Page… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 116 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Duet ™ spinal fixation construct is intended to provide immobilization and stabilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L1-S1: degenerative disk disease (ODD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262712: Duet™ Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262712
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026