510(k) Report

510(k) · Cleared

Cleared

GII Spinal Fixation System

K210306510(k) SpecialCleared May 19, 2021105-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

Coligne AG · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 19, 2021 as substantially equivalent to K083567 (Co-Ligne AG, 2009) and 2 other predicates after a 105-day review. Its family tree reaches back 20 generations to 2004.

Decided
May 19, 2021
Review
105 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 20 generations to K040583 (2004). 227 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 4 other ancestors2004: 21 other ancestors2014: 4 other ancestors2005: 17 other ancestors2001: 17 other ancestors1998: 13 other ancestors2013: 5 other ancestors2011: 5 other ancestors2003: 12 other ancestors2002: 12 other ancestors2000: 19 other ancestors1999: 4 other ancestors1996: 6 other ancestors2015: 1 other ancestor2012: 1 other ancestor2010: 5 other ancestors2008: 12 other ancestors2006: 10 other ancestors1995: 8 other ancestors2007: 7 other ancestors1997: 7 other ancestors1994: 4 other ancestors1988: 2 other ancestors1987: 1 other ancestor1984: 2 other ancestors1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 1 other ancestor1978: 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) 19801990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 19 other ancestors4 generations back: 26 other ancestors5 generations back: 41 other ancestors6 generations back: 44 other ancestors7 generations back: 30 other ancestors8 generations back: 23 other ancestors9 generations back: 12 other ancestors10 generations back: 5 other ancestors K202771 · 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 · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations between
  3. 3 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  4. 2 generations backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
  5. 1 generation backK202771 CD Horizon Spinal SystemMedtronic · 2020
  6. This deviceK210306 GII Spinal Fixation SystemColigne AG · 2021
Show all 20 generations
  1. Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 7 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 6 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 5 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 4 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 3 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 2 generations backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
  20. 1 generation backK202771 CD Horizon Spinal SystemMedtronic · 2020
  21. This deviceK210306 GII Spinal Fixation SystemColigne AG · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−17K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−16K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−15K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−13K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−12K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−11K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−10K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−9K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−8K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−7K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−4K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−3K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2020—
−1K202771CD Horizon Spinal SystemMedtronic2020—
0 (this device)K210306GII Spinal Fixation SystemColigne AG2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198510
198620
198710
198820
198910
199010
199220
199440
199580
199660
199770
1998130
199940
2000190
2001170
2002120
2003120
2004210
2005170
2006100
200770
2008120
200940
201050
201150
201210
201350
201440
201510
FIG. 1 — Lineage of K210306, 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.

Planning a device in NKB? 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? (3)

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
*K083567Gii Spinal Fixation System, Gii-TI-Poly Axial Screw
Summary page 4
…equivalent to the following devices currently in commercial use: Primary Predicate Device Device: GII-Ti-Poly-Axial Screw Company: Coligne AG 510(k) number: K083567 Additional Predicate Devices Device: GII Spinal Fixation System Company: Coligne AG 510(k) number: K032604 Device: C…
Co-Ligne AG2009—
*K032604Gii Spinal Fixation System
Summary page 4
…xial Screw Company: Coligne AG 510(k) number: K083567 Additional Predicate Devices Device: GII Spinal Fixation System Company: Coligne AG 510(k) number: K032604 Device: CD Horizon Spinal System Company: Medtronic 510(k) number: K202771…
Co-Ligne AG2004—
*K202771CD Horizon Spinal System
Summary page 4
…ces Device: GII Spinal Fixation System Company: Coligne AG 510(k) number: K032604 Device: CD Horizon Spinal System Company: Medtronic 510(k) number: K202771 K210306…
Medtronic2020—

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 17 years and passes through 5 companies; a new generation was cleared every 7 months on median.
  • 25 of the 227 ancestors have a recall of any class.

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 Coligne GII Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use for one or more of the following: (1) degenerative disc…

Read the full statement (193 words)

The Coligne GII Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in

skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical

posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal

Fixation System is intended for use for one or more of the following: (1) degenerative disc disease (defined as discogenic

back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis

with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or

curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Coligne GII Spinal Fixation System

is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat

pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor

and/or trauma.

This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior

approach.

Indications for use as stated in the FDA summary.

More from Coligne AG

4 FDA decisions under this applicant name. See the company

  • K181963ostaPek Interbody Fusion CagesColigne AG · 2018
  • K173893TrabisColigne AG · 2018
  • K173148ACIFColigne AG · 2017

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/K210306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210306: GII Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210306

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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