510(k) · Cleared
ClearedGii Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karen E. Warden, M.E.B.E. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 1, 1998 after a 57-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- May 1, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK980852 Gii Spinal Fixation SystemKaren E. Warden, M.E.B.E. · 1998
- Descendant · cites it directly · 5 of its ownK032604 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K032604Gii Spinal Fixation SystemCo-Ligne AG · 2004 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980852 | Gii Spinal Fixation System | Karen E. Warden, M.E.B.E. | 1998 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (6)
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?
- Of its descendants, K032604 (Co-Ligne AG, 2004) has gone furthest, with 5 descendants of its own.
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?
The GII Spinal Fixation System using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of pedicle screw fixation may be from L3 to the sacrum.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980852: Gii Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980852
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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