510(k) Report

510(k) · Cleared

Cleared

M.U.S.T. Midline Cortical (MC) Screw System

K210427510(k) TraditionalCleared Apr 20, 202168-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 Apr 20, 2021 as substantially equivalent to K171170 (Medacta International S.A., 2017) and 4 other predicates after a 68-day review. Its family tree reaches back 17 generations to 2004. 1 of the 149 devices in its family, counting itself, has a Class I recall.

Decided
Apr 20, 2021
Review
68 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
5

Its longest line of descent runs back 17 generations to K040583 (2004). 148 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 149 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2017: 1 other ancestor2007: 6 other ancestors2010: 5 other ancestors, 1 with a Class I recall12009: 3 other ancestors2005: 13 other ancestors2004: 17 other ancestors2003: 13 other ancestors1999: 4 other ancestors1998: 4 other ancestors1997: 3 other ancestors2011: 1 other ancestor2008: 4 other ancestors2006: 8 other ancestors2002: 7 other ancestors2001: 11 other ancestors2000: 13 other ancestors1995: 3 other ancestors1994: 1 other ancestor1996: 3 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1984: 1 other ancestor×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. · 201719801990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 16 other ancestors, 1 with a Class I recall13 generations back: 29 other ancestors4 generations back: 46 other ancestors5 generations back: 16 other ancestors6 generations back: 12 other ancestors7 generations back: 10 other ancestors K171170 · 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 · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations between
  3. 3 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
  4. 2 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
  5. 1 generation backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
  6. This deviceK210427 M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A. · 2021
Show all 17 generations
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 5 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  14. 4 generations backK132878 M.U.S.T. ExtensionMedacta International · 2013
  15. 3 generations backK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
  16. 2 generations backK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
  17. 1 generation backK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
  18. This deviceK210427 M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A. · 2021

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

GenerationNumberDeviceApplicantDecidedRecalls
−17K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−14K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−12K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−10K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−9K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−8K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−7K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−6K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−5K121115M.U.S.T Pedicle Screw SystemMedacta International20121
−4K132878M.U.S.T. ExtensionMedacta International2013—
−3K141988M.U.S.T Pedicle Screw SystemMedacta International2014—
−2K153664M.U.S.T. Pedicle Screw SystemMedacta International2016—
−1K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional…Medacta International S.A.2017—
0 (this device)K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199020
199250
199320
199410
199530
199630
199730
199840
199940
2000130
2001110
200270
2003130
2004170
2005130
200680
200760
200840
200930
201051
201110
201710
FIG. 1 — Lineage of K210427, 2004–2021Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
Summary 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, K171170, Medacta International SA Additional predicate devices:  M.U.S.T. Pedicle Screw System, K121115, Medacta International SA…
Medacta International S.A.2017—
*K121115M.U.S.T Pedicle Screw System
Summary page 4
…ices: Primary predicate device:  M.U.S.T. Pedicle Screw System, K171170, Medacta International SA Additional predicate devices:  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. Combined Set Screws…
Medacta International20121
*K153664M.U.S.T. Pedicle Screw System
Summary page 4
…171170, Medacta International SA Additional predicate devices:  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. Combined Set Screws, K171758, Medacta International SA  Valeo Pedicle Screw System, K…
Medacta International2016—
*K171758M.U.S.T. Combined Set Screws
Summary page 4
…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. Combined Set Screws, K171758, Medacta International SA  Valeo Pedicle Screw System, K072022, Amedica Corp.…
Medacta International S.A.2017—
*K072022Valeo Pedicle Screw Spinal System
Summary page 4
… M.U.S.T. Pedicle Screw System, K153664, Medacta International SA  M.U.S.T. Combined Set Screws, K171758, Medacta International SA  Valeo Pedicle Screw System, K072022, Amedica Corp. K210427 - Page…
Amedica Corp.2007—

Also cleared against K171170: 7 other devices →

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 17 years and passes through 5 companies; a new generation was cleared every 8 months on median.
  • 22 of the 148 ancestors have a recall of any class; 1 has a Class I recall.
  • 7 other devices also cite its predicate K171170.

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. 2021, 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 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.

Also cleared against K171170

7 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
  • K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A. · 2021
  • K203367LineSider™ Spinal SystemIntegrity Implants, Inc. · 20204 recalls
  • K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine · 2020
  • K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2020

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/K210427 · printed Nov 4, 2026

Cite this page

510(k) Report. “K210427: M.U.S.T. Midline Cortical (MC) Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210427

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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