510(k) Report

510(k) · Cleared

Cleared

M.U.S.T. MINI Posterior Cervical Screws System

K171369510(k) TraditionalCleared Aug 1, 201783-day reviewClass II21 CFR 888.3075

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. · NKG Posterior Cervical Screw System

Cleared on Aug 1, 2017 as substantially equivalent to K142838 (Synthes USA Products, LLC, 2015) and 12 other predicates after an 83-day review. Its family tree reaches back 17 generations to 2004. 1 of the 242 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.

Decided
Aug 1, 2017
Review
83 days
Class
Class II
Product code
NKG
Recalls
None
Predicates
13

Its longest line of descent runs back 17 generations to K040583 (2004). 233 ancestors in all, the oldest K781443 (1978). 8 later devices descend from it, 4 citing it directly. 1 of the 242 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 1 other ancestor2015: 1 other ancestor2013: 1 other ancestor2012: 4 other ancestors2011: 4 other ancestors2007: 11 other ancestors2003: 19 other ancestors2002: 14 other ancestors1999: 9 other ancestors2014: 1 other ancestor2010: 8 other ancestors, 1 with a Class I recall12009: 6 other ancestors2008: 9 other ancestors2005: 21 other ancestors2004: 32 other ancestors2001: 16 other ancestors2000: 15 other ancestors1998: 6 other ancestors2006: 14 other ancestors1997: 5 other ancestors1995: 3 other ancestors1996: 3 other ancestors1994: 1 other ancestor1985: 1 other ancestor1978: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2020: 4 descendants cleared2022: 1 descendant cleared2019: 1 descendant cleared2026: 2 descendants 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. · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 20 other ancestors, 1 with a Class I recall13 generations back: 55 other ancestors4 generations back: 37 other ancestors5 generations back: 47 other ancestors6 generations back: 16 other ancestors7 generations back: 15 other ancestors8 generations back: 13 other ancestors9 generations back: 3 other ancestors10 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant 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 deviceK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
  7. Descendant · cites it directly · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
  8. Descendant · 2 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
  9. Descendant · 3 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
  10. Descendant · cites it directly · 1 of its ownK182837 M.U.S.T. Mini ExtensionMedacta International S.A. · 2019
  11. Descendant · 4 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
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 deviceK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019: 12020: 42022: 12026: 2
2019high 4 (2020) · low 0 (2021)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 8 · See all
  • K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · cites it directly6descendants
  • K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on3descendants
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 3 generations on1descendant
  • K182837M.U.S.T. Mini ExtensionMedacta International S.A. · 2019 · cites it directly1descendant
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 4 generations on0descendants
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)K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.2017—
+1K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.2020—
+2K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.2020—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For…Alphatec Spine, Inc.2026—
+1K182837M.U.S.T. Mini ExtensionMedacta International S.A.2019—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation…Alphatec Spine, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199320
199410
199530
199630
199750
199860
199990
2000150
2001160
2002140
2003190
2004320
2005210
2006140
2007110
200890
200960
201081
201140
201240
201310
201410
201510
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202040
202210
202620
FIG. 1 — Lineage of K171369, 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 NKG device

  1. #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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? (13)

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
*K142838Synapse Occipital-Cervical-Thoracic (OCT) System
Summary page 4
…classified III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: • Synapse Occipital-Cervical-Thoracic (OCT) System, K142838, Synthes USA Products, LLC (also referred to as Synthes’ Synapse System) Additional Predicates • Synapse System, K070573,…
Synthes USA Products, LLC20151
*K070573Synapse System
Summary page 4
…Occipital-Cervical-Thoracic (OCT) System, K142838, Synthes USA Products, LLC (also referred to as Synthes’ Synapse System) Additional Predicates • Synapse System, K070573, Synthes Spine Co. LP, (also referred to as Synthes’ Synapse System) • Synthes Cervifix/Axon, K023675, Synthes (USA), (also…
Synthes Spine Co.Lp2007—
*K023675Synthes Cervifix/ Axon
Summary page 4
…es’ Synapse System) Additional Predicates • Synapse System, K070573, Synthes Spine Co. LP, (also referred to as Synthes’ Synapse System) • Synthes Cervifix/Axon, K023675, Synthes (USA), (also referred to as Synthes’ Axon System) • Synthes Cervifix System, K991089, Synthes Spine, (also referre…
Synthes (Usa)2002—
*K991089Synthes Cervifix System
Summary page 4
…eferred to as Synthes’ Synapse System) • Synthes Cervifix/Axon, K023675, Synthes (USA), (also referred to as Synthes’ Axon System) • Synthes Cervifix System, K991089, Synthes Spine, (also referred to as Synthes’ Axon System) • Vertex Reconstruction System, Vertex Select Reconstruction Sys…
Synthes Spine1999—
*K123906Vertex Reconstruction System, Vertext Select Reconstruction System
Summary page 4
…• Synthes Cervifix System, K991089, Synthes Spine, (also referred to as Synthes’ Axon System) • Vertex Reconstruction System, Vertex Select Reconstruction System, K123906, Medtronic Sofamor Danek USA, Inc. (also referred to as Medtronic’s Vertex) • Exactech Gibralt Spinal System, K110197, Exac…
Medtronic Sofamor Danek USA, Inc.2013—
*K110197Exactech Gibralt Spinal System
Summary page 4
…System, Vertex Select Reconstruction System, K123906, Medtronic Sofamor Danek USA, Inc. (also referred to as Medtronic’s Vertex) • Exactech Gibralt Spinal System, K110197, Exactech, Inc. • Blackstone Posterior Cervical System, K030197, Blackstone Medical, Inc.…
Exactech, Inc.20111
*K030197Blackstone Posterior Cervical System
Summary page 4
…Sofamor Danek USA, Inc. (also referred to as Medtronic’s Vertex) • Exactech Gibralt Spinal System, K110197, Exactech, Inc. • Blackstone Posterior Cervical System, K030197, Blackstone Medical, Inc.…
Blackstone Medical, Inc.20031
*K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System
Summary page 5
…Page 2 of 8 • Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System, K121725, Pioneer Surgical Technology • M.U.S.T. Extension, K132878, Medacta International SA (also known as M.U.S.T. Pedicle…
Pioneer Surgical Technology, Inc.2012—
*K132878M.U.S.T. Extension
Summary page 5
…Page 2 of 8 • Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System, K121725, Pioneer Surgical Technology • M.U.S.T. Extension, K132878, Medacta International SA (also known as M.U.S.T. Pedicle Screws System) • M.U.S.T. Pedicle Screws System, K141988, Medac…
Medacta International2013—
*K141988M.U.S.T Pedicle Screw System
Summary page 5
…gical Technology • M.U.S.T. Extension, K132878, Medacta International SA (also known as M.U.S.T. Pedicle Screws System) • M.U.S.T. Pedicle Screws System, K141988, Medacta International SA • M.U.S.T. Pedicle Screws System, K153664, Medacta International SA • M.U.S.T. Pedicle Screws Sys…
Medacta International2014—
*K153664M.U.S.T. Pedicle Screw System
Summary page 5
…tional SA (also known as M.U.S.T. Pedicle Screws System) • M.U.S.T. Pedicle Screws System, K141988, Medacta International SA • M.U.S.T. Pedicle Screws System, K153664, Medacta International SA • M.U.S.T. Pedicle Screws System, K162061, Medacta International SA • M.U.S.T. Pedicle Screw Syst…
Medacta International2016—
*K162061M.U.S.T. Pedicle Screw System
Summary page 5
…S.T. Pedicle Screws System, K141988, Medacta International SA • M.U.S.T. Pedicle Screws System, K153664, Medacta International SA • M.U.S.T. Pedicle Screws System, K162061, Medacta International SA • M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws, K171170,…
Medacta International S.A.2016—
*K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
Cleared while this submission was under review
Summary page 5
…SA • M.U.S.T. Pedicle Screws System, K162061, Medacta International SA • M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws, K171170, Medacta International SA IV. Device Description The purpose of this submission is to gain clearance for the M.U.S.T. MINI Po…
Medacta International S.A.2017—

Also cleared against K142838: 31 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206
K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191
K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220
K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200

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 13 years and passes through 5 companies; a new generation was cleared every 5 months on median.
  • 31 of the 233 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K200130 (Medacta International S.A., 2020) has gone furthest, with 6 descendants of its own.
  • 31 other devices also cite its predicate K142838.

How does its category compare?

All NKG devices

NKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · NKG

6in 2025

2015: 172016: 162017: 152018: 122019: 82020: 142021: 72022: 72023: 102024: 32025: 62026 (partial year): 4
2007high 17 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKG

58in 2025

2015: 71 days median2016: 87 days median2017: 108 days median2018: 61 days median2019: 50 days median2020: 59 days median2021: 56 days median2022: 108 days median2023: 58 days median2024: 100 days median2025: 58 days median2026 (partial year): 169 days median
2007high 169 (2026) · low 50 (2019)2026

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

Recalls per year · NKG

2in 2020

2018: 12019: 12020: 2
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NKG

153in 2025

2015: 42016: 732017: 992018: 1272019: 2142020: 2362021: 7042022: 1752023: 1312024: 2062025: 153
2007high 704 (2021) · low 0 (2007)2025

MAUDE reports naming product code NKG, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
2015177104
20161687073
201715108099
201812611127
20198501214
202014592236
20217560704
202271080175
202310580131
202431000206
20256580153
202641690—

What is it indicated for?

The M.U.S.T. Mini posterior cervical screwV system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease…

Read the full statement (207 words)

The M.U.S.T. Mini posterior cervical screwV system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The M.U.S.T. Mini posterior cervical screwV system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the M.U.S.T. Mini posterior cervical screwV system may be connected to the M.U.S.T. system rods with the M.U.S.T. Mini rod connectors. Transition rods with differing diameters may also be used to connect the M.U.S.T. Mini posterior cervical screwV system to the M.U.S.T. system. Refer to the M.U.S.T. system package insert for a list of the M.U.S.T. indications of use.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K171369: M.U.S.T. MINI Posterior Cervical Screws System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171369

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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