510(k) · Cleared
ClearedModification to Global Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Feb 17, 2005 as substantially equivalent to K001668 (D.K.M. Co., Ltd., 2000) and 2 other predicates after a 118-day review. Its family tree reaches back 2 generations to 2000. 124 later devices descend from it.
- Decided
- Feb 17, 2005
- Review
- 118 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K992147 (2000). 3 ancestors in all, the oldest K980485 (1998). 124 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 1 generation backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- This deviceK042928 Modification to Global Spinal Fixation SystemU&I Corp. · 2005
- Descendant · cites it directly · 123 of its ownK103085 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- Descendant · 2 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- Descendant · 3 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011 · cites it directly123descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 2 generations on111descendants
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 3 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −1 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| 0 (this device) | K042928 | Modification to Global Spinal Fixation System | U&I Corp. | 2005 | — |
| +1 | K103085 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| +2 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| +3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| +3 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 16 | 0 |
| 2024 | 13 | 0 |
| 2025 | 11 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K001668 | Global Spinal Fixation SystemSummary page 1…is substantially equivalent in function, design, composition, labeling, and intended use to: GLOBAL SPINAL FIXATION SYSTEMTM, Spinal System MNH, MNI - (K001668). TRIPLE-FIX Spinal Fixation System - KWP, MNH, MNI -- (K992147) ISOLA Spinal System -- MNH, MNI, KWQ -- (K980485… | 2000 |
| * | K992147 | Triple-Fix Spinal Fixation SystemSummary page 1…abeling, and intended use to: GLOBAL SPINAL FIXATION SYSTEMTM, Spinal System MNH, MNI - (K001668). TRIPLE-FIX Spinal Fixation System - KWP, MNH, MNI -- (K992147) ISOLA Spinal System -- MNH, MNI, KWQ -- (K980485) The substantial equivalence of this device is based on equiva… | 2000 |
| * | K980485 | Isola Spinal SystemSummary page 1…ION SYSTEMTM, Spinal System MNH, MNI - (K001668). TRIPLE-FIX Spinal Fixation System - KWP, MNH, MNI -- (K992147) ISOLA Spinal System -- MNH, MNI, KWQ -- (K980485) The substantial equivalence of this device is based on equivalence in intended use, materials, designs and oper… | 1998 |
What descends from it? (124)
See all 1241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103085 | Venus Basic Spinal Fixation System | 2011 | 123 |
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 5 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103085 (L&K BIOMED Co., Ltd., 2011) has gone furthest, with 123 descendants of its own.
- 15 other devices also cite its predicate K001668.
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 GLOBAL SPINAL FIXATION SYSTEM posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the GLOBAL SPINAL FIXATION SYSTEM is intended…
Read the full statement (127 words)
The GLOBAL SPINAL FIXATION SYSTEM posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the GLOBAL SPINAL FIXATION SYSTEM is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042928: Modification to Global Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042928
Report an extraction error
Are you the manufacturer?
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