510(k) · Cleared
ClearedM.U.S.T. Pedicle Screw System - Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 28, 2026 as substantially equivalent to K234048 (Medacta International S.A., 2024) and 3 other predicates after a 140-day review. Its family tree reaches back 20 generations to 2004. 1 of the 338 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 28, 2026
- Review
- 140 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K040583 (2004). 337 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 338 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
- 2 generations backK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
- 1 generation backK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
- This deviceK253940 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 7 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
- 6 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
- 5 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 4 generations backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- 3 generations backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
- 2 generations backK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
- 1 generation backK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
- This deviceK253940 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −7 | K132878 | M.U.S.T. Extension | Medacta International | 2013 | — |
| −6 | K141988 | M.U.S.T Pedicle Screw System | Medacta International | 2014 | — |
| −5 | K153664 | M.U.S.T. Pedicle Screw System | Medacta International | 2016 | — |
| −4 | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional… | Medacta International S.A. | 2017 | — |
| −3 | K193365 | M.U.S.T. Pedicle Screw System | Medacta International S.A. | 2020 | — |
| −2 | K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab Implants | Medacta International S.A. | 2021 | — |
| −1 | K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024 | — |
| 0 (this device) | K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 0 |
| 1998 | 14 | 0 |
| 1999 | 13 | 0 |
| 2000 | 24 | 0 |
| 2001 | 24 | 0 |
| 2002 | 19 | 0 |
| 2003 | 20 | 0 |
| 2004 | 25 | 0 |
| 2005 | 21 | 0 |
| 2006 | 18 | 0 |
| 2007 | 15 | 0 |
| 2008 | 17 | 0 |
| 2009 | 15 | 0 |
| 2010 | 18 | 1 |
| 2011 | 11 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K234048 | M.U.S.T. Pedicle Screw System - ExtensionSummary page 5…3070, 21 CFR 888.3050, 21 CFR 888.3060 Device Classification II III. Predicate Devices Primary Predicate: • M.U.S.T. Pedicle Screw System – Extension, K234048 Additional Predicates: • M.U.S.T. Extension, K141044 • M.U.S.T. Pedicle Screw System, K162061 • M.U.S.T. Pe… | 2024 |
| * | K141044 | M.U.S.T. ExtensionSummary page 5…II III. Predicate Devices Primary Predicate: • M.U.S.T. Pedicle Screw System – Extension, K234048 Additional Predicates: • M.U.S.T. Extension, K141044 • M.U.S.T. Pedicle Screw System, K162061 • M.U.S.T. Pedicle Screw System, K193365 IV. Device Description The… | 2014 |
| * | K162061 | M.U.S.T. Pedicle Screw SystemSummary page 5…edicate: • M.U.S.T. Pedicle Screw System – Extension, K234048 Additional Predicates: • M.U.S.T. Extension, K141044 • M.U.S.T. Pedicle Screw System, K162061 • M.U.S.T. Pedicle Screw System, K193365 IV. Device Description The M.U.S.T. Pedicle Screw System - Extension includ… | 2016 |
| * | K193365 | M.U.S.T. Pedicle Screw SystemSummary page 5…– Extension, K234048 Additional Predicates: • M.U.S.T. Extension, K141044 • M.U.S.T. Pedicle Screw System, K162061 • M.U.S.T. Pedicle Screw System, K193365 IV. Device Description The M.U.S.T. Pedicle Screw System - Extension includes the following implants: • M.U.S.T. Lateral… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 33 of the 337 ancestors have a recall of any class; 1 has a Class I recall.
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 M.U.S.T. Pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of 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/K253940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253940: M.U.S.T. Pedicle Screw System - Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253940
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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