510(k) Report

510(k) · Cleared

Cleared

M.U.S.T. Pedicle Screw System

K162061510(k) TraditionalCleared Oct 21, 201687-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 Oct 21, 2016 as substantially equivalent to K121115 (Medacta International, 2012) and 6 other predicates after an 87-day review. Its family tree reaches back 15 generations to 2004. 1 of the 164 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.

Decided
Oct 21, 2016
Review
87 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 15 generations to K040583 (2004). 148 ancestors in all, the oldest K781443 (1978). 15 later devices descend from it, 4 citing it directly. 1 of the 164 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2004: 17 other ancestors1999: 5 other ancestors1998: 5 other ancestors2010: 5 other ancestors, 1 with a Class I recall12009: 3 other ancestors2007: 6 other ancestors2005: 13 other ancestors2003: 13 other ancestors2011: 1 other ancestor2008: 4 other ancestors2006: 8 other ancestors2002: 7 other ancestors2001: 11 other ancestors2000: 13 other ancestors1997: 3 other ancestors1995: 3 other ancestors1996: 3 other ancestors1994: 1 other ancestor1978: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2021: 1 descendant cleared2017: 1 descendant cleared2024: 2 descendants cleared2026: 5 descendants cleared2020: 4 descendants cleared2022: 1 descendant cleared2019: 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 · 2013K141044 · M.U.S.T. Extension · Medacta International · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 10 other ancestors, 1 with a Class I recall13 generations back: 31 other ancestors4 generations back: 40 other ancestors5 generations back: 26 other ancestors6 generations back: 12 other ancestors7 generations back: 10 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K141044 · M.U.S.T. Extension · 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+5
  1. Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 11 generations between
  3. 3 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  4. 2 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
  5. 1 generation backK141044 M.U.S.T. ExtensionMedacta International · 2014
  6. This deviceK162061 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2016
  7. Descendant · cites it directly · 8 of its ownK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
  8. Descendant · 2 generations on · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
  9. Descendant · cites it directly · 5 of its ownK203482 M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
  10. Descendant · 3 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
  11. Descendant · 2 generations on · 2 of its ownK241034 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024
Show all 15 generations
  1. Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 3 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  14. 2 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
  15. 1 generation backK141044 M.U.S.T. ExtensionMedacta International · 2014
  16. This deviceK162061 M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2016

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2017: 12019: 12020: 42021: 12022: 12024: 22026: 5
2017high 5 (2026) · low 0 (2018)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010

Most influential descendants

Showing 5 of 15 · See all
  • K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017 · cites it directly8descendants
  • K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 2 generations on6descendants
  • K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021 · cites it directly5descendants
  • K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on3descendants
  • K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−14K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−13K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−12K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−10K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−8K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−7K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−6K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−5K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−3K121115M.U.S.T Pedicle Screw SystemMedacta International20121
−2K132878M.U.S.T. ExtensionMedacta International2013—
−1K141044M.U.S.T. ExtensionMedacta International2014—
0 (this device)K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.2016—
+1K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.2017—
+2K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.2020—
+1K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.2021—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.2020—
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199020
199250
199320
199410
199530
199630
199730
199850
199950
2000130
2001110
200270
2003130
2004170
2005130
200680
200760
200840
200930
201051
201110
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201910
202040
202110
202210
202420
202650
FIG. 1 — Lineage of K162061, 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? (7)

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
*K121115M.U.S.T Pedicle Screw System
Summary page 4
…21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Device Class: III PREDICATE DEVICE INFORMATION Primary Predicate: M.U.S.T. Pedicle Screw System, K121115, Medacta International SA Additional Predicates M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Extens…
Medacta International20121
*K141988M.U.S.T Pedicle Screw System
Summary page 4
…PREDICATE DEVICE INFORMATION Primary Predicate: M.U.S.T. Pedicle Screw System, K121115, Medacta International SA Additional Predicates M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Extension, K141044, Medacta International SA M.U.S.T. Extension, K132878, Medacta Internationa…
Medacta International2014—
*K141044M.U.S.T. Extension
Summary page 4
….S.T. Pedicle Screw System, K121115, Medacta International SA Additional Predicates M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Extension, K141044, Medacta International SA M.U.S.T. Extension, K132878, Medacta International SA Expendium Spine System, K041119, DePuy Spine, Inc…
Medacta International2014—
*K132878M.U.S.T. Extension
Summary page 4
…onal SA Additional Predicates M.U.S.T. Pedicle Screw System, K141988, Medacta International SA M.U.S.T. Extension, K141044, Medacta International SA M.U.S.T. Extension, K132878, Medacta International SA Expendium Spine System, K041119, DePuy Spine, Inc.…
Medacta International2013—
*K041119Expedium Spine System
Summary page 4
…em, K141988, Medacta International SA M.U.S.T. Extension, K141044, Medacta International SA M.U.S.T. Extension, K132878, Medacta International SA Expendium Spine System, K041119, DePuy Spine, Inc.…
Depuy Spine, Inc.2004—
*K984578Synergy D2 Spinal Implants
Summary page 5
…K162061 Page 2 of 5 Synergy D2 Spinal Implants, K984578, Interpore Cross International MOSS Miami Spinal System, K983583, DePuy Inc. DEVICE DESCRIPTION The M.U.S.T. Pedicle Screw Syste…
Interpore Cross Intl.1999—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 5
…Page 2 of 5 Synergy D2 Spinal Implants, K984578, Interpore Cross International MOSS Miami Spinal System, K983583, DePuy Inc. DEVICE DESCRIPTION The M.U.S.T. Pedicle Screw System devices are fixation devices intended for the stabilization and…
Depuy, Inc.1998—

Also cleared against K121115: 12 other devices →

What descends from it? (15)

See all 15

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178
K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215
K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241
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 12 years and passes through 5 companies; a new generation was cleared every 5 months on median.
  • 22 of the 148 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K171369 (Medacta International S.A., 2017) has gone furthest, with 8 descendants of its own.
  • 12 other devices also cite its predicate K121115.

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. 2016, 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 K121115

12 other devices cite the same predicate.

  • K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A. · 2024
  • K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A. · 2024
  • K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A. · 2021
  • K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
  • K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020
  • K171758M.U.S.T. Combined Set ScrewsMedacta International S.A. · 2017

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/K162061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162061: 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/K162061

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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