510(k) · Cleared
ClearedM.U.S.T. Pedicle Screw Extension and Long Tab Implants
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 Jan 26, 2021 as substantially equivalent to K153664 (Medacta International, 2016) and 7 other predicates after a 60-day review. Its family tree reaches back 18 generations to 2004. 1 of the 159 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jan 26, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 18 generations to K040583 (2004). 153 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly. 1 of the 159 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 2 generations backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- 1 generation backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
- This deviceK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
- Descendant · cites it directly · 2 of its ownK241034 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024
- Descendant · cites it directly · 1 of its ownK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
- Descendant · 2 generations on · 0 of its ownK260286 Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253940 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
- Descendant · 2 generations on · 0 of its ownK252885 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2026
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 5 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
- 4 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
- 3 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 2 generations backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- 1 generation backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
- This deviceK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 5 of 5 · See all- K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024 · cites it directly2descendants
- K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024 · cites it directly1descendant
- K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026 · 2 generations on0descendants
- K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
- K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −5 | K132878 | M.U.S.T. Extension | Medacta International | 2013 | — |
| −4 | K141988 | M.U.S.T Pedicle Screw System | Medacta International | 2014 | — |
| −3 | K153664 | M.U.S.T. Pedicle Screw System | Medacta International | 2016 | — |
| −2 | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional… | Medacta International S.A. | 2017 | — |
| −1 | K193365 | M.U.S.T. Pedicle Screw System | Medacta International S.A. | 2020 | — |
| 0 (this device) | K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab Implants | Medacta International S.A. | 2021 | — |
| +1 | K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | 2024 | — |
| +1 | K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024 | — |
| +2 | K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | 2026 | — |
| +2 | K253940 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2026 | — |
| +2 | K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 1 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 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.
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? (8)
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 |
|---|---|---|---|
| * | K153664 | M.U.S.T. Pedicle Screw SystemSummary page 4…ification II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: M.U.S.T. Pedicle Screw System, K153664, Medacta International SA Reference predicate devices: M.U.S.T. Pedicle Screw System, K121115, Medacta International SA… | 2016 |
| * | K121115 | M.U.S.T Pedicle Screw SystemSummary page 4…vices: Primary predicate device: M.U.S.T. Pedicle Screw System, K153664, Medacta International SA Reference predicate devices: M.U.S.T. Pedicle Screw System, K121115, Medacta International SA M.U.S.T. Pedicle Screw System, K132878, Medacta International SA M.U.S.T. Pedicle Screw Syste… | 2012 |
| * | K132878 | M.U.S.T. ExtensionSummary page 4…K153664, Medacta International SA Reference predicate devices: M.U.S.T. Pedicle Screw System, K121115, Medacta International SA M.U.S.T. Pedicle Screw System, K132878, Medacta International SA M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Pedicle Screw Syste… | 2013 |
| * | K141988 | M.U.S.T Pedicle Screw SystemSummary page 4….U.S.T. Pedicle Screw System, K121115, Medacta International SA M.U.S.T. Pedicle Screw System, K132878, Medacta International SA M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Pedicle Screw System, K162061, Medacta International SA M.U.S.T. Pedicle Screw Syste… | 2014 |
| * | K162061 | M.U.S.T. Pedicle Screw SystemSummary page 4….U.S.T. Pedicle Screw System, K132878, Medacta International SA M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Pedicle Screw System, K162061, Medacta International SA M.U.S.T. Pedicle Screw System, K171170, Medacta International SA M.U.S.T. Combined Set Screws… | 2016 |
| * | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsSummary page 4….U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Pedicle Screw System, K162061, Medacta International SA M.U.S.T. Pedicle Screw System, K171170, Medacta International SA M.U.S.T. Combined Set Screws, K171758, Medacta International SA M.U.S.T. Pedicle Screw System… | 2017 |
| * | K171758 | M.U.S.T. Combined Set ScrewsSummary page 4…M.U.S.T. Pedicle Screw System, K162061, Medacta International SA M.U.S.T. Pedicle Screw System, K171170, Medacta International SA M.U.S.T. Combined Set Screws, K171758, Medacta International SA M.U.S.T. Pedicle Screw System, K193365, Medacta International SA IV. Device Description The M… | 2017 |
| * | K193365 | M.U.S.T. Pedicle Screw SystemSummary page 4…M.U.S.T. Pedicle Screw System, K171170, Medacta International SA M.U.S.T. Combined Set Screws, K171758, Medacta International SA M.U.S.T. Pedicle Screw System, K193365, Medacta International SA IV. Device Description The M.U.S.T. Extension and M.U.S.T. Long Tab is intended to be used as part… | 2020 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 22 of the 153 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241034 (Medacta International S.A., 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K153664.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 screws 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 as stated in the FDA summary.
https://510kreport.com/device/K203482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203482: M.U.S.T. Pedicle Screw Extension and Long Tab Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203482
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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