510(k) · Cleared
ClearedMedyssey CO., LTD., Zenius Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey Co, Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jun 25, 2010 as substantially equivalent to K020279 (Forex Corp., 2002) and 1 other predicate after a 267-day review. Its family tree reaches back 4 generations to 1996. 20 later devices descend from it.
- Decided
- Jun 25, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K955348 (1996). 9 ancestors in all, the oldest K933881 (1994). 20 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 3 generations backK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- 2 generations backK070300 Expedium SFX Cross Connector SystemDepuy Spine, Inc. · 2007 · Recalled
- 1 generation backK081153 Novel Spinal SystemMedyssey Co, Ltd. · 2009
- This deviceK093104 Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- Descendant · cites it directly · 15 of its ownK103272 Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- Descendant · cites it directly · 14 of its ownK110283 Zenius Spinal SystemMedyssey Co, Ltd. · 2011
- Descendant · 2 generations on · 11 of its ownK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
- Descendant · 2 generations on · 8 of its ownK131878 Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK160731 LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K103272Zenius Spinal SystemMedyssey Co, Ltd. · 2010 · cites it directly15descendants
- K110283Zenius Spinal SystemMedyssey Co, Ltd. · 2011 · cites it directly14descendants
- K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013 · 2 generations on11descendants
- K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013 · 2 generations on8descendants
- K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −3 | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| −2 | K070300 | Expedium SFX Cross Connector System | Depuy Spine, Inc. | 2007 | 1 |
| −1 | K081153 | Novel Spinal System | Medyssey Co, Ltd. | 2009 | — |
| 0 (this device) | K093104 | Medyssey CO., LTD., Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| +1 | K103272 | Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| +1 | K110283 | Zenius Spinal System | Medyssey Co, Ltd. | 2011 | — |
| +2 | K121670 | Medyssey Cannulated Pedicle Screw | Medyssey Co, Ltd. | 2013 | — |
| +2 | K131878 | Lliad, Kora, Zenius Pedicle Screw System | Medyssey USA, Inc. | 2013 | — |
| +1 | K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020279 | Forex Corporation, Optima, Spinal SystemSummary page 1…070 * Spondylolisthesis Spinal Fixation Device System (MNH) 21 CFR § 888.3070 4. Predicate Device: U&I Corporation, OPTIMATM Spinal System - MNI, MNH, KWQ -- (K020279 and K024098) Medyssey Co. Ltd., NOVELTm Spinal System - MNH, MNI - (KO8i1153) 5. Device Description:… | 2002 |
| Kept off the family tree | K024098 | FDA’s K024098 is Cobas Integra Creatinine Plus Ver.2 Assay Our reading of the summary gave K024098, FDA’s number for Cobas Integra Creatinine Plus Ver.2 Assay (Roche Diagnostics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “U&I Corporation, OPTIMA Spinal System”. Kept off the family tree. Summary page 1…xation Device System (MNH) 21 CFR § 888.3070 4. Predicate Device: U&I Corporation, OPTIMATM Spinal System - MNI, MNH, KWQ -- (K020279 and K024098) Medyssey Co. Ltd., NOVELTm Spinal System - MNH, MNI - (KO8i1153) 5. Device Description: The Medyssey Co. Ltd., Zen/us T… | 2002 |
| * | K081153 | Novel Spinal System | 2009 |
What descends from it? (20)
See all 205 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 14 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K103272 (Medyssey Co, Ltd., 2010) has gone furthest, with 15 descendants of its own.
- 8 other devices also cite its predicate K020279.
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 Medyssey Co. Ltd., ZeniusTm Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral…
Read the full statement (99 words)
The Medyssey Co. Ltd., ZeniusTm Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic 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/K093104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093104: Medyssey CO., LTD., Zenius Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093104
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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