510(k) Report

510(k) · Cleared

Cleared

Gii Spinal Fixation System, Gii-TI-Poly Axial Screw

K083567510(k) SpecialCleared Sep 14, 2009285-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

Co-Ligne AG · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Sep 14, 2009 as substantially equivalent to K980852 (Karen E. Warden, M.E.B.E., 1998) and 2 other predicates after a 285-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.

Decided
Sep 14, 2009
Review
285 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K944736 (1995). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 4 other ancestors1996: 2 other ancestors2021: 1 descendant clearedK944736 · VSP (Variable Screw Placement) · Acromed Corp. · 1995K981274 · Acromed Timx Plate Based Low Back System · Acromed Corp. · 1998K010576 · Monarch Spine System · Depuyacromed · 2001K032604 · Gii Spinal Fixation System · Co-Ligne AG · 2004K051089 · Gii Spinal Fixation System · Co-Ligne AG · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant K051089 · Gii Spinal Fixation System · Co-Ligne AG · 2005K032604 · Gii Spinal Fixation System · Co-Ligne AG · 2004K010576 · Monarch Spine System · Depuyacromed · 2001K981274 · Acromed Timx Plate Based Low Back System · Acromed Corp. · 1998K944736 · VSP (Variable Screw Placement) · Acromed Corp. · 1995−50
  1. Root · 5 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
  2. 4 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
  3. 3 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
  4. 2 generations backK032604 Gii Spinal Fixation SystemCo-Ligne AG · 2004
  5. 1 generation backK051089 Gii Spinal Fixation SystemCo-Ligne AG · 2005
  6. This deviceK083567 Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG · 2009
  7. Descendant · cites it directly · 0 of its ownK210306 GII Spinal Fixation SystemColigne AG · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K210306GII Spinal Fixation SystemColigne AG · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K944736VSP (Variable Screw Placement)Acromed Corp.1995—
−4K981274Acromed Timx Plate Based Low Back SystemAcromed Corp.1998—
−3K010576Monarch Spine SystemDepuyacromed2001—
−2K032604Gii Spinal Fixation SystemCo-Ligne AG2004—
−1K051089Gii Spinal Fixation SystemCo-Ligne AG2005—
0 (this device)K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG2009—
+1K210306GII Spinal Fixation SystemColigne AG2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199840

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K083567, 1995–2021Source: 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 MNH? 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
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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
*K980852Gii Spinal Fixation System
Summary page 1
…of the GII- Ti-Poly-Axial Screw is substantially equivalent to the screws currently offered in the GIH Spinal Fixation System identified below: K980852 - K032604 and K051089 - GII Spinal Fixation System Equivalence can be seen in the comparable design, material compositio…
Karen E. Warden, M.E.B.E.1998—
*K032604Gii Spinal Fixation System
Summary page 1
…I- Ti-Poly-Axial Screw is substantially equivalent to the screws currently offered in the GIH Spinal Fixation System identified below: K980852 - K032604 and K051089 - GII Spinal Fixation System Equivalence can be seen in the comparable design, material composition, surgica…
Co-Ligne AG2004—
*K051089Gii Spinal Fixation System
Summary page 1
…i-Poly-Axial Screw is substantially equivalent to the screws currently offered in the GIH Spinal Fixation System identified below: K980852 - K032604 and K051089 - GII Spinal Fixation System Equivalence can be seen in the comparable design, material composition, surgical technique,…
Co-Ligne AG2005—

Also cleared against K980852: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K210306GII Spinal Fixation SystemColigne AG20210

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 14 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K210306 (Coligne AG, 2021) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K980852.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally-mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following: (1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-SI) joint with objective evidence of neurologic impairment, (2)Fracture, (3) Dislocation…

Read the full statement (150 words)

The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally-mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-SI) joint with objective evidence of neurologic impairment,

(2)Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(6) Spinal tumor, and/or

(7)Failed previous fusion (pseudoarthrosis).

The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1)Degenerative spondylolisthesis with objective evidence of neurologic impairment,

(2)Fracture,

(3)Dislocation,

(4)Scoliosis,

(5)Kyphosis,

(7)Spinal tumor, and/or

(8)Failed previous fusion (pseudoarthrosis).

Indications for use as stated in the FDA summary.

Also cleared against K980852

2 other devices cite the same predicate.

  • K051089Gii Spinal Fixation SystemCo-Ligne AG · 2005
  • K032604Gii Spinal Fixation SystemCo-Ligne AG · 2004

More from Co-Ligne AG

4 FDA decisions under this applicant name. See the company

  • K072326Ostapek VBR SystemCo-Ligne AG · 2008
  • K051089Gii Spinal Fixation SystemCo-Ligne AG · 2005
  • K032604Gii Spinal Fixation SystemCo-Ligne AG · 2004

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K083567 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083567: Gii Spinal Fixation System, Gii-TI-Poly Axial Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083567

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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