510(k) · Cleared
ClearedM.U.S.T. Pedicle Screw System
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 27, 2020 as substantially equivalent to K132878 (Medacta International, 2013) and 4 other predicates after a 54-day review. Its family tree reaches back 17 generations to 2004. 1 of the 155 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Jan 27, 2020
- Review
- 54 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K040583 (2004). 147 ancestors in all, the oldest K781443 (1978). 7 later devices descend from it, 3 citing it directly. 1 of the 155 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
- 2 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 1 generation backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- This deviceK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
- Descendant · cites it directly · 5 of its ownK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
- Descendant · 2 generations on · 2 of its ownK241034 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024
- Descendant · 2 generations on · 1 of its ownK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
- Descendant · 3 generations on · 0 of its ownK260286 Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253940 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 4 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
- 3 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
- 2 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
- 1 generation backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
- This deviceK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 5 of 7 · See all- K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021 · cites it directly5descendants
- K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024 · 2 generations on2descendants
- K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024 · 2 generations on1descendant
- K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc. · 2026 · 3 generations on0descendants
- K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −4 | K132878 | M.U.S.T. Extension | Medacta International | 2013 | — |
| −3 | K141988 | M.U.S.T Pedicle Screw System | Medacta International | 2014 | — |
| −2 | K153664 | M.U.S.T. Pedicle Screw System | Medacta International | 2016 | — |
| −1 | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional… | Medacta International S.A. | 2017 | — |
| 0 (this device) | K193365 | M.U.S.T. Pedicle Screw System | Medacta International S.A. | 2020 | — |
| +1 | K203482 | M.U.S.T. Pedicle Screw Extension and Long Tab Implants | Medacta International S.A. | 2021 | — |
| +2 | K241034 | Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System | Medacta International S.A. | 2024 | — |
| +2 | K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. | 2024 | — |
| +3 | K260286 | Dynamo™ Spinal Cement; Salvo® Spine System | Spine Wave, Inc. | 2026 | — |
| +1 | 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 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K132878 | M.U.S.T. ExtensionSummary page 4…evice Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: M.U.S.T. Extension, K132878, Medacta International Additional predicate devices: M.U.S.T. Extension Straight Connector and Additional Screws, K171170,… | 2013 |
| * | K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsSummary page 4…redicate device: M.U.S.T. Extension, K132878, Medacta International Additional predicate devices: M.U.S.T. Extension Straight Connector and Additional Screws, K171170, Medacta International SA M.U.S.T. Pedicle Screw System, K121115, Medacta International SA M.U.S.T. Pedicle Scre… | 2017 |
| * | K121115 | M.U.S.T Pedicle Screw SystemSummary page 4…itional predicate devices: M.U.S.T. Extension Straight Connector and Additional Screws, K171170, Medacta International SA M.U.S.T. Pedicle Screw System, K121115, Medacta International SA M.U.S.T. Pedicle Screw System, K153664, Medacta International SA M.U.S.T. Pedicle Screw Syste… | 2012 |
| * | K153664 | M.U.S.T. Pedicle Screw SystemSummary page 4…and Additional Screws, K171170, Medacta International SA M.U.S.T. Pedicle Screw System, K121115, Medacta International SA M.U.S.T. Pedicle Screw System, K153664, Medacta International SA M.U.S.T. Pedicle Screw System, K141988, Medacta International SA IV. Device Description The pu… | 2016 |
| * | 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, K153664, Medacta International SA M.U.S.T. Pedicle Screw System, K141988, Medacta International SA IV. Device Description The purpose of this submission is to add the M.U.S.T. MC Cross Connectors to… | 2014 |
What descends from it? (7)
3 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 16 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 22 of the 147 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203482 (Medacta International S.A., 2021) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K132878.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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/K193365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193365: M.U.S.T. Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193365
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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