510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

M.U.S.T Pedicle Screw System

K121115510(k) TraditionalCleared Jul 18, 201297-day reviewClass II21 CFR 888.3050Recalls 1

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

Medacta International · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jul 18, 2012 as substantially equivalent to K091445 (Medtronic Sofamor Danek, 2010) and 9 other predicates after a 97-day review. Its family tree reaches back 12 generations to 2004. 1 of the 186 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it. It has been recalled once.

Decided
Jul 18, 2012
Review
97 days
Class
Class II
Product code
KWP
Recalls
1
Predicates
10

Its longest line of descent runs back 12 generations to K040583 (2004). 142 ancestors in all, the oldest K781443 (1978). 43 later devices descend from it, 13 citing it directly. 1 of the 186 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 5 other ancestors, 1 with a Class I recall12009: 3 other ancestors2007: 6 other ancestors2004: 17 other ancestors2003: 13 other ancestors2011: 1 other ancestor2008: 4 other ancestors2006: 8 other ancestors2005: 13 other ancestors2002: 7 other ancestors2001: 11 other ancestors2000: 13 other ancestors1999: 4 other ancestors1998: 4 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 ancestor2017: 3 descendants cleared2024: 2 descendants cleared2016: 4 descendants cleared2021: 4 descendants cleared2014: 3 descendants cleared2020: 9 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2018: 3 descendants cleared2026: 6 descendants cleared2022: 2 descendants cleared2019: 1 descendant cleared2023: 4 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors, 1 with a Class I recall12 generations back: 31 other ancestors3 generations back: 42 other ancestors4 generations back: 26 other ancestors5 generations back: 12 other ancestors6 generations back: 10 other ancestors 1 generation forward: 13 descendants2 generations forward: 10 descendants3 generations forward: 11 descendants4 generations forward: 6 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K113174 · 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 · 2004−10−50+5
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 8 generations between
  3. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  4. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  5. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  6. This deviceK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012
  7. Descendant · cites it directly · 28 of its ownK132878 M.U.S.T. ExtensionMedacta International · 2013
  8. Descendant · cites it directly · 26 of its ownK141988 M.U.S.T Pedicle Screw SystemMedacta International · 2014
  9. Descendant · cites it directly · 24 of its ownK153664 M.U.S.T. Pedicle Screw SystemMedacta International · 2016
  10. Descendant · cites it directly · 23 of its ownK171170 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and…Medacta International S.A. · 2017
  11. Descendant · cites it directly · 16 of its ownK141044 M.U.S.T. ExtensionMedacta International · 2014
Show all 12 generations
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. This deviceK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2013: 12014: 32015: 12016: 42017: 32018: 32019: 12020: 92021: 42022: 22023: 42024: 22026: 6
2013high 9 (2020) · low 0 (2025)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix Systemdirect predicate · 2010

Most influential descendants

Showing 5 of 43 · See all
  • K132878M.U.S.T. ExtensionMedacta International · 2013 · cites it directly28descendants
  • K141988M.U.S.T Pedicle Screw SystemMedacta International · 2014 · cites it directly26descendants
  • K153664M.U.S.T. Pedicle Screw SystemMedacta International · 2016 · cites it directly24descendants
  • K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A. · 2017 · cites it directly23descendants
  • K141044M.U.S.T. ExtensionMedacta International · 2014 · cites it directly16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−10K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−9K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−7K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−6K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−5K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−4K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
0 (this device)K121115M.U.S.T Pedicle Screw SystemMedacta International2012—
+1K132878M.U.S.T. ExtensionMedacta International2013—
+1K141988M.U.S.T Pedicle Screw SystemMedacta International2014—
+1K153664M.U.S.T. Pedicle Screw SystemMedacta International2016—
+1K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional…Medacta International S.A.2017—
+1K141044M.U.S.T. ExtensionMedacta International2014—

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201430
201510
201640
201730
201830
201910
202090
202140
202220
202340
202420
202660
FIG. 1 — Lineage of K121115, 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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (10)

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
*K091445CD Horizon Spinal System
Summary page 1
…ixation, for degenerative disc dlsease , 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Class Il Devic_e Product Codes: MNI, MNH, NKB, KWQ, KWP Predicate Devices: K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedi…
Medtronic Sofamor Danek2010—
*K042962Modification to CD Horizon Spinal System
Summary page 1
…dlsease , 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Class Il Devic_e Product Codes: MNI, MNH, NKB, KWQ, KWP Predicate Devices: K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119…
Medtronic Sofamor Danek2004—
*K022949Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss
Summary page 1
…1 CFR 888.3060, 21 CFR 888.3050 Class Il Devic_e Product Codes: MNI, MNH, NKB, KWQ, KWP Predicate Devices: K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393…
Synthes (Usa)2003—
*K100952Modification to Synthes Matrix System
Summary page 1
…3050 Class Il Devic_e Product Codes: MNI, MNH, NKB, KWQ, KWP Predicate Devices: K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Sol…
Synthes Spine2010Class I
*K072022Valeo Pedicle Screw Spinal System
Summary page 1
…t Codes: MNI, MNH, NKB, KWQ, KWP Predicate Devices: K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Solera, Medtronic K113174 Solera,…
Amedica Corp.2007—
*K024096Optima, Spinal System
Summary page 1
…KWQ, KWP Predicate Devices: K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Solera, Medtronic K113174 Solera, Medtronic M.U.S.T. pe…
U&I Corp., America20033
*K041119Expedium Spine System
Summary page 1
…Devices: K091445 CD Horizon, Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Solera, Medtronic K113174 Solera, Medtronic M.U.S.T. pedicle screw system 5…
Depuy Spine, Inc.2004—
*K083393Xia 3 Spinal System
Summary page 1
…Medtronic K042962 CD Horizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Solera, Medtronic K113174 Solera, Medtronic M.U.S.T. pedicle screw system 510(k) Section 5 - Page 2 of 4…
Stryker Spine20091
*K101074Modification to: CD Horizon (R) Spinal System
Summary page 1
…rizon, Medtronic K022949 USS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Solera, Medtronic K113174 Solera, Medtronic M.U.S.T. pedicle screw system 510(k) Section 5 - Page 2 of 4 Produc…
Medtronic Sofamor Danek USA, Inc.2010—
*K113174CD Horizon Spinal System
Summary page 1
…SS, Synthes Spine K100952 Matrix, Synthes Spine K072022 Valeo, Amedica K024096 Optima, U&I K041119 Expedium, DePuy Spine K083393 XIA 3, Stryker K101074 Solera, Medtronic K113174 Solera, Medtronic M.U.S.T. pedicle screw system 510(k) Section 5 - Page 2 of 4 Product Description The M.U.S.T…
Medtronic Sofamor Danek USA, Inc.20111

Also cleared against K091445: 26 other devices →

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K132878M.U.S.T. ExtensionMedacta International201328
K141988M.U.S.T Pedicle Screw SystemMedacta International201426
K153664M.U.S.T. Pedicle Screw SystemMedacta International201624
K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723
K141044M.U.S.T. ExtensionMedacta International201416
K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615
K132788Myspine Pedicle Screw Placement GuidesMedacta International201412
K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207
K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177
K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 7, 2016Class IIZ-1023-2017PackagingDamaged packaging, lack of sterility assurance

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 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 21 of the 142 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K132878 (Medacta International, 2013) has gone furthest, with 28 descendants of its own.
  • 26 other devices also cite its predicate K091445.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

The M.U.S.T. pedlicle screw system is intended for posterior non-cervical pedicle fixation (Ti -S2/ilium) or anterolateral fixation (TB-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 lordlosis); tumor; pseudloarthrosis; and failed previous fusion in skeletally mature patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K091445

26 other devices cite the same predicate.

  • K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti. · 2024
  • K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC · 2023
  • K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC · 2018
  • K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp. · 20153 recalls
  • K141044M.U.S.T. ExtensionMedacta International · 2014
  • K140765Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014

More from Medacta International

39 FDA decisions under this applicant name. See the company

  • K160605MectaLIF Anterior Stand-AloneMedacta International · 2016
  • K160289MasterLoc StemMedacta International · 2016
  • K153664M.U.S.T. Pedicle Screw SystemMedacta International · 2016
  • K151531MasterLoc StemMedacta International · 2015
  • K142744Mecta-C TiPEEKMedacta International · 2015

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K121115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121115: 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/K121115

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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