510(k) Report

510(k) · Cleared

Cleared

LigaPASS™ System

K261374510(k) SpecialCleared May 27, 202630-day reviewClass II21 CFR 888.3010

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

Medicrea International S.A.S · OWI Bone Fixation Cerclage, Sublaminar

Cleared on May 27, 2026 as substantially equivalent to K211057 (Medtronic, Inc., 2021) and 1 other predicate after a 30-day review. Its family tree reaches back 21 generations to 2004.

Decided
May 27, 2026
Review
30 days
Class
Class II
Product code
OWI
Recalls
None
Predicates
2

Its longest line of descent runs back 21 generations to K040583 (2004). 230 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2018: 1 other ancestor2017: 1 other ancestor2016: 1 other ancestor2014: 5 other ancestors2013: 6 other ancestors2011: 6 other ancestors2004: 20 other ancestors2003: 12 other ancestors2002: 12 other ancestors2000: 19 other ancestors1999: 4 other ancestors2015: 1 other ancestor2012: 2 other ancestors2010: 5 other ancestors2009: 4 other ancestors2008: 13 other ancestors2006: 11 other ancestors2005: 16 other ancestors1997: 8 other ancestors2007: 7 other ancestors2001: 16 other ancestors1996: 5 other ancestors1994: 4 other ancestors1993: 1 other ancestor1992: 3 other ancestors1998: 8 other ancestors1995: 7 other ancestors1988: 2 other ancestors1987: 1 other ancestor1984: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1978: 1 other ancestor1985: 1 other ancestor1990: 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) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017×2: 2 generations cleared close together, K201407 (2020), K202771 (2020) K211057 · LigaPASS® Spinal System, CD Horizon™ Spinal System · Medtronic, Inc. · 202119801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 17 other ancestors5 generations back: 29 other ancestors6 generations back: 47 other ancestors7 generations back: 45 other ancestors8 generations back: 39 other ancestors9 generations back: 13 other ancestors10 generations back: 10 other ancestors11 generations back: 5 other ancestors K211057 · LigaPASS® Spinal System, CD Horizon™ Spinal System · Medtronic, Inc. · 2021K202771 · CD Horizon Spinal System · Medtronic · 2020K201407 · CD Horizon™ Spinal System · Medtronic Sofamor Danek USA, Inc. · 2020K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · 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 · 2004−20−15−10−50
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations between
  3. 3 generations backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
  4. 2 generations backK202771 CD Horizon Spinal SystemMedtronic · 2020
  5. 1 generation backK211057 LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc. · 2021
  6. This deviceK261374 LigaPASS™ SystemMedicrea International S.A.S · 2026
Show all 21 generations
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 8 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 7 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 6 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 5 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 4 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 3 generations backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
  20. 2 generations backK202771 CD Horizon Spinal SystemMedtronic · 2020
  21. 1 generation backK211057 LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc. · 2021
  22. This deviceK261374 LigaPASS™ SystemMedicrea International S.A.S · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−18K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−16K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−14K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−13K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−12K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−11K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−10K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−9K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−7K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2020—
−2K202771CD Horizon Spinal SystemMedtronic2020—
−1K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.2021—
0 (this device)K261374LigaPASS™ SystemMedicrea International S.A.S2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198510
198620
198710
198820
198910
199010
199230
199310
199440
199570
199650
199780
199880
199940
2000190
2001160
2002120
2003120
2004200
2005160
2006110
200770
2008130
200940
201050
201160
201220
201360
201450
201510
201610
201710
201810
FIG. 1 — Lineage of K261374, 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.

Planning a device in OWI? 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 OWI device

  1. #1 K253615 Invictus Bands Systemscore 20.7 · 33 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? (2)

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
*K211057LigaPASS® Spinal System, CD Horizon™ Spinal System
Summary page 5
…888.3010 Product Code(s) oWl | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211057 LigaPASS Spinal System, CD Horizon Spinal System owl K173506 LigaPASS Spinal System owl Device Description Summary 21 CFR 807.92(…
Medtronic, Inc.2021—
*K173506LigaPASS
Summary page 5
…evices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211057 LigaPASS Spinal System, CD Horizon Spinal System owl K173506 LigaPASS Spinal System owl Device Description Summary 21 CFR 807.92(a)(4) The LigaPASS™ MEDICREA™ INTERNATIONAL S.A.S. spinal sy…
Medicrea International SA2018—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 7 months on median.
  • 25 of the 230 ancestors have a recall of any class.

How does its category compare?

All OWI devices

OWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · OWI

2in 2023

2011: 12013: 22014: 32015: 32016: 52017: 72018: 42019: 32020: 32021: 12022: 12023: 22026 (partial year): 2
2007high 7 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWI

60in 2020

2014: 92 days median2015: 93 days median2016: 98 days median2017: 77 days median2018: 156 days median2019: 51 days median2020: 60 days median
2007high 156 (2018) · low 51 (2019)2026

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

Recalls per year · OWI

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · OWI

6in 2025

2014: 12015: 12016: 62017: 62018: 22019: 132020: 82021: 52022: 62023: 42024: 32025: 6
2007high 13 (2019) · low 0 (2007)2025

MAUDE reports naming product code OWI, 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
20111—00
20120—00
20132—00
201439201
201539301
201659806
201777706
2018415602
2019351013
202036018
20211—05
20221—06
20232—04
20240—03
20250—06
20262—0—

What is it indicated for?

The LigaPASS ™ System is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use are as follows: - Spinal trauma surgery, used in sublaminar or facet wiring techniques; - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such…

Read the full statement (146 words)

The LigaPASS ™ System is an implant for use in orthopaedic surgery. The system is intended to provide

temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of

bone fractures. The indications for use are as follows:

- Spinal trauma surgery, used in sublaminar or facet wiring techniques;

- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal

deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult

scoliosis and kyphosis,

- Spinal degenerative surgery, as an adjunct to spinal fusions,

- Intended for use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The LigaPASS ™ system may also be used in conjunction with other medical grade implants made of

titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

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

Recent decisions in OWI

The OWI category page

  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K222097OLYMPIC Deformity Band SystemAstura Medical · 2023
  • K230565HILINE™ Fixation SystemGlobus Medical, Inc. · 2023
  • K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022
  • K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc. · 2021

https://510kreport.com/device/K261374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261374: LigaPASS™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261374

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026