510(k) · Cleared
ClearedFixpine II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 19, 2010 as substantially equivalent to K060702 (Solco Biomedical Co., Ltd., 2006) and 1 other predicate after a 124-day review. Its family tree reaches back 4 generations to 2000. 23 later devices descend from it.
- Decided
- Jul 19, 2010
- Review
- 124 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000319 (2000). 9 ancestors in all. 23 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- This deviceK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- Descendant · cites it directly · 13 of its ownK132101 Anax 5.5 Spinal SystemU&I Corporation · 2013
- Descendant · cites it directly · 11 of its ownK111362 Rexious Spinal Fixation SystemDio Medical Co., Ltd. · 2011
- Descendant · 2 generations on · 6 of its ownK160731 LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK143417 ANAX 5.5 Spinal SystemU&I Corporation · 2015
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K132101Anax 5.5 Spinal SystemU&I Corporation · 2013 · cites it directly13descendants
- K111362Rexious Spinal Fixation SystemDio Medical Co., Ltd. · 2011 · cites it directly11descendants
- K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016 · 2 generations on6descendants
- K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017 · 2 generations on5descendants
- K143417ANAX 5.5 Spinal SystemU&I Corporation · 2015 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −1 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| 0 (this device) | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| +1 | K132101 | Anax 5.5 Spinal System | U&I Corporation | 2013 | — |
| +1 | K111362 | Rexious Spinal Fixation System | Dio Medical Co., Ltd. | 2011 | — |
| +2 | K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016 | — |
| +2 | K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | 2017 | — |
| +1 | K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 MNI? 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? (2)
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 |
|---|---|---|---|
| * | K060702 | 4CIS Vane Spine SystemSummary page 2…omy Model. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: * 4CI5® Vane Spine System (Solco Biomedical Co., Ltd.; K060702) * GSS Pedicle Screw System (GS Medical Co., Ltd.; K053573) Comparison to Predicate Devices: Testing and other comparisons hav… | 2006 |
| * | K053573 | GSS Pedicle Screw SystemSummary page 2…antially equivalent to the following predicate devices: * 4CI5® Vane Spine System (Solco Biomedical Co., Ltd.; K060702) * GSS Pedicle Screw System (GS Medical Co., Ltd.; K053573) Comparison to Predicate Devices: Testing and other comparisons have established that the subject of Fixpine 11 System is subs… | 2006 |
What descends from it? (23)
See all 237 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132101 | Anax 5.5 Spinal System | 2013 | 13 |
| K111362 | Rexious Spinal Fixation System | 2011 | 11 |
| K143417 | ANAX 5.5 Spinal System | 2015 | 4 |
| K132365 | Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation | 2013 | 2 |
| K231737 | ANAX™ 5.5 Spinal System | 2023 | 1 |
| K222415 | Rexious Spinal Fixation System | 2022 | 1 |
| K131522 | Core Pedicle Screw System | 2013 | 0 |
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 10 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K132101 (U&I Corporation, 2013) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K060702.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Fixpine II System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrumn) with removal of the implants after the attainment of a solid fusion. In addition, the Fixpine II System is intended to provide immobilization and stabilization of…
Read the full statement (122 words)
The Fixpine II System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrumn) with removal of the implants after the attainment of a solid fusion.
In addition, the Fixpine II 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/K100765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100765: Fixpine II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100765
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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