510(k) · Cleared
ClearedGii Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Co-Ligne AG · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 20, 2004 as substantially equivalent to K980852 (Karen E. Warden, M.E.B.E., 1998) and 2 other predicates after a 148-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Jan 20, 2004
- Review
- 148 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944736 (1995). 9 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 2 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 1 generation backK010576 Monarch Spine SystemDepuyacromed · 2001
- This deviceK032604 Gii Spinal Fixation SystemCo-Ligne AG · 2004
- Descendant · cites it directly · 4 of its ownK051089 Gii Spinal Fixation SystemCo-Ligne AG · 2005
- Descendant · 2 generations on · 1 of its ownK192930 Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020
- Descendant · cites it directly · 1 of its ownK083567 Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG · 2009
- Descendant · 3 generations on · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK210306 GII Spinal Fixation SystemColigne AG · 2021
Most influential descendants
Showing 5 of 5 · See all- K051089Gii Spinal Fixation SystemCo-Ligne AG · 2005 · cites it directly4descendants
- K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC · 2020 · 2 generations on1descendant
- K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG · 2009 · cites it directly1descendant
- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 3 generations on0descendants
- K210306GII Spinal Fixation SystemColigne AG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −2 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −1 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| 0 (this device) | K032604 | Gii Spinal Fixation System | Co-Ligne AG | 2004 | — |
| +1 | K051089 | Gii Spinal Fixation System | Co-Ligne AG | 2005 | — |
| +2 | K192930 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | 2020 | — |
| +1 | K083567 | Gii Spinal Fixation System, Gii-TI-Poly Axial Screw | Co-Ligne AG | 2009 | — |
| +3 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K210306 | GII Spinal Fixation System | Coligne AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980852 | Gii Spinal Fixation SystemSummary page 1…and 1II) PRODUCT CODE: MNII/MNI/KWP PANEL: Orthopedic Devices PREDICATE DEVICES: GII Spinal Fixation System (K980852), Isola Spinal System (K9804 85) and Monarch (KO 10576). DEVICE DESCRIPTION: The GII Spinal Fix… | 1998 |
| * | K980485 | Isola Spinal SystemSummary page 1…Orthopedic Devices PREDICATE DEVICES: GII Spinal Fixation System (K980852), Isola Spinal System (K9804 85) and Monarch (KO 10576). DEVICE DESCRIPTION: The GII Spinal Fixation System implants are intended to be used… | 1998 |
| * | K010576 | Monarch Spine System | 2001 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K051089 (Co-Ligne AG, 2005) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K980852.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation…
Read the full statement (226 words)
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032604: 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/K032604
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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