510(k) · Cleared
ClearedRexious Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Medical Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 21, 2011 as substantially equivalent to K100765 (Dio Medical Co., Ltd., 2010) after a 66-day review. Its family tree reaches back 5 generations to 2000. 11 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000319 (2000). 10 ancestors in all. 11 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 3 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 2 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 1 generation backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- This deviceK111362 Rexious Spinal Fixation SystemDio Medical Co., Ltd. · 2011
- Descendant · cites it directly · 5 of its ownK173131 Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK132365 Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK222415 Rexious Spinal Fixation SystemDio Medical Corporation · 2022
- Descendant · cites it directly · 1 of its ownK210420 Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK140219 Picasso II Mis Spinal SystemAccel Spine · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd. · 2017 · cites it directly5descendants
- K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine · 2013 · cites it directly2descendants
- K222415Rexious Spinal Fixation SystemDio Medical Corporation · 2022 · cites it directly1descendant
- K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021 · cites it directly1descendant
- K140219Picasso II Mis Spinal SystemAccel Spine · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −4 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −3 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −2 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −1 | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| 0 (this device) | K111362 | Rexious Spinal Fixation System | Dio Medical Co., Ltd. | 2011 | — |
| +1 | K173131 | Rexious Spinal Fixation System | Huvexel Co., Ltd. | 2017 | — |
| +1 | K132365 | Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation | Accel Spine | 2013 | 2 |
| +1 | K222415 | Rexious Spinal Fixation System | Dio Medical Corporation | 2022 | — |
| +1 | K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | 2021 | — |
| +2 | K140219 | Picasso II Mis Spinal System | Accel Spine | 2014 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 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? (1)
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 |
|---|---|---|---|
| * | K100765 | Fixpine II SystemSummary page 2…fore no additional testing was performed. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: * Fixpine 11 System (K 100765) Comparison to Predicate Devices: The comparisons have established that the subject of Rexious Spinal Fixation System is substa… | 2010 |
What descends from it? (11)
See all 117 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173131 | Rexious Spinal Fixation System | 2017 | 5 |
| K132365 | Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation | 2013 | 2 |
| K222415 | Rexious Spinal Fixation System | 2022 | 1 |
| K210420 | Goblin and Goblin LS Pedicle Screw Systems | 2021 | 1 |
| K220285 | PINE Pedicle Screw System | 2022 | 0 |
| K191655 | MEGAFIX® Pedicle Screw Spinal System | 2020 | 0 |
| 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 11 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K173131 (Huvexel Co., Ltd., 2017) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K100765.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Rexious Spinal Fixation System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S I 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 afttainment of a solid fusion. In addition, the Rexious Spinal Fixation System is intended to provide…
Read the full statement (125 words)
The Rexious Spinal Fixation System is a posterior pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S I 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 afttainment of a solid fusion.
In addition, the Rexious 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/K111362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111362: Rexious 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/K111362
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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