510(k) Report

510(k) · Cleared

Cleared

M.U.S.T. Pedicle Screw System - Extension

K234048510(k) TraditionalCleared Feb 13, 202454-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medacta International S.A. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Feb 13, 2024 as substantially equivalent to K203482 (Medacta International S.A., 2021) and 8 other predicates after a 54-day review. Its family tree reaches back 19 generations to 2004. 1 of the 338 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Feb 13, 2024
Review
54 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
9

Its longest line of descent runs back 19 generations to K040583 (2004). 336 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 338 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2019: 1 other ancestor2017: 3 other ancestors2016: 1 other ancestor2015: 2 other ancestors2018: 1 other ancestor2014: 2 other ancestors2013: 3 other ancestors2012: 5 other ancestors2011: 11 other ancestors2010: 18 other ancestors, 1 with a Class I recall12009: 15 other ancestors2008: 17 other ancestors2007: 15 other ancestors2006: 18 other ancestors2004: 25 other ancestors2003: 20 other ancestors2002: 19 other ancestors2000: 24 other ancestors1999: 13 other ancestors1998: 14 other ancestors1997: 9 other ancestors1996: 10 other ancestors1995: 8 other ancestors2005: 21 other ancestors2001: 24 other ancestors1994: 3 other ancestors1993: 4 other ancestors1992: 5 other ancestors1990: 3 other ancestors1978: 1 other ancestor1984: 1 other ancestor1985: 1 other ancestor2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121115 · M.U.S.T Pedicle Screw System · Medacta International · 2012 · recalledK132878 · M.U.S.T. Extension · Medacta International · 2013K141988 · M.U.S.T Pedicle Screw System · Medacta International · 2014K153664 · M.U.S.T. Pedicle Screw System · Medacta International · 2016K171170 · M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws · Medacta International S.A. · 2017K193365 · M.U.S.T. Pedicle Screw System · Medacta International S.A. · 2020K203482 · M.U.S.T. Pedicle Screw Extension and Long Tab Implants · Medacta International S.A. · 202119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 37 other ancestors, 1 with a Class I recall13 generations back: 83 other ancestors4 generations back: 76 other ancestors5 generations back: 48 other ancestors6 generations back: 38 other ancestors7 generations back: 22 other ancestors8 generations back: 9 other ancestors 1 generation forward: 1 descendant K203482 · M.U.S.T. Pedicle Screw Extension and Long Tab Implants · Medacta International S.A. · 2021K193365 · M.U.S.T. Pedicle Screw System · Medacta International S.A. · 2020K171170 · M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws · Medacta International S.A. · 2017K153664 · M.U.S.T. Pedicle Screw System · Medacta International · 2016K141988 · M.U.S.T Pedicle Screw System · Medacta International · 2014K132878 · M.U.S.T. Extension · Medacta International · 2013K121115 · M.U.S.T Pedicle Screw System · Medacta International · 2012 · recalledK113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
  4. 2 generations backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
  5. 1 generation backK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
  6. This deviceK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
  7. Descendant · cites it directly · 0 of its ownK253940 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  14. 6 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
  15. 5 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
  16. 4 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
  17. 3 generations backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
  18. 2 generations backK193365 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
  19. 1 generation backK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
  20. This deviceK234048 M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010

Most influential descendants

Showing 1 of 1 · See all
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121115M.U.S.T Pedicle Screw SystemMedacta International20121
−6K132878M.U.S.T. ExtensionMedacta International2013—
−5K141988M.U.S.T Pedicle Screw SystemMedacta International2014—
−4K153664M.U.S.T. Pedicle Screw SystemMedacta International2016—
−3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional…Medacta International S.A.2017—
−2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.2020—
−1K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.2021—
0 (this device)K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2024—
+1K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199030
199250
199340
199430
199580
1996100
199790
1998140
1999130
2000240
2001240
2002190
2003200
2004250
2005210
2006180
2007150
2008170
2009150
2010181
2011110
201250
201330
201420
201520
201610
201730
201810
201910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K234048, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K203482M.U.S.T. Pedicle Screw Extension and Long Tab Implants
Summary page 4
…II. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device:  M.U.S.T. Pedicle Screw Extension, K203482, Medacta International SA Additional Predicate devices  Apex-DL Spine System, K143683, SpineCraft LLC  Wh…
Medacta International S.A.2021—
*K143683APEX-DL Spine System
Summary page 4
…rimary Predicate device:  M.U.S.T. Pedicle Screw Extension, K203482, Medacta International SA Additional Predicate devices  Apex-DL Spine System, K143683, SpineCraft LLC  Whistler Modular Pedicle Screw System, K182478, Evolution Spine LLC  M.U.S.T. Pedicle Screw Syst…
Spinecraft, LLC2015—
*K182478Whistler Modular Pedicle Screw System
Summary page 4
…482, Medacta International SA Additional Predicate devices  Apex-DL Spine System, K143683, SpineCraft LLC  Whistler Modular Pedicle Screw System, K182478, Evolution Spine LLC  M.U.S.T. Pedicle Screw System, K171170, Medacta International SA  M.U.S.T. Pedicle Screw Sy…
Evolution Spine, LLC2019—
*K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
Summary page 4
… Apex-DL Spine System, K143683, SpineCraft LLC  Whistler Modular Pedicle Screw System, K182478, Evolution Spine LLC  M.U.S.T. Pedicle Screw System, K171170, Medacta International SA  M.U.S.T. Pedicle Screw System, K162061, Medacta International SA  M.U.S.T. Pedicle Scr…
Medacta International S.A.2017—
*K162061M.U.S.T. Pedicle Screw System
Summary page 4
…ular Pedicle Screw System, K182478, Evolution Spine LLC  M.U.S.T. Pedicle Screw System, K171170, Medacta International SA  M.U.S.T. Pedicle Screw System, K162061, Medacta International SA  M.U.S.T. Pedicle Screw System, K141988, Medacta International SA  M.U.S.T. Pedicle Scr…
Medacta International S.A.2016—
*K141988M.U.S.T Pedicle Screw System
Summary page 4
…Pedicle Screw System, K171170, Medacta International SA  M.U.S.T. Pedicle Screw System, K162061, Medacta International SA  M.U.S.T. Pedicle Screw System, K141988, Medacta International SA  M.U.S.T. Pedicle Screw System, K132878, Medacta International SA  M.U.S.T. Pedicle Scr…
Medacta International2014—
*K132878M.U.S.T. Extension
Summary page 4
…Pedicle Screw System, K162061, Medacta International SA  M.U.S.T. Pedicle Screw System, K141988, Medacta International SA  M.U.S.T. Pedicle Screw System, K132878, Medacta International SA  M.U.S.T. Pedicle Screw System, K121115, Medacta International SA  M.U.S.T. Sacral Ilia…
Medacta International2013—
*K121115M.U.S.T Pedicle Screw System
Summary page 4
…Pedicle Screw System, K141988, Medacta International SA  M.U.S.T. Pedicle Screw System, K132878, Medacta International SA  M.U.S.T. Pedicle Screw System, K121115, Medacta International SA  M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, K171595, Medacta International SA === P…
Medacta International20121
*K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Summary page 4
…132878, Medacta International SA  M.U.S.T. Pedicle Screw System, K121115, Medacta International SA  M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, K171595, Medacta International SA K23…
Medacta International S.A.2017—

Also cleared against K203482: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260

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 20 years and passes through 5 companies; a new generation was cleared every 8 months on median.
  • 33 of the 336 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K253940 (Medacta International S.A., 2026) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K203482.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

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 as stated in the FDA summary.

Also cleared against K203482

1 other device cites the same predicate.

  • K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024

More from Medacta International S.A.

167 FDA decisions under this applicant name. See the company

  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254202MectaLIF 3D Metal AnteriorMedacta International S.A. · 2026
  • K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2026
  • K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K234048 · printed Nov 4, 2026

Cite this page

510(k) Report. “K234048: 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/K234048

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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