510(k) · Cleared
ClearedZenius 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 May 19, 2011 as substantially equivalent to K093104 (Medyssey Co, Ltd., 2010) and 1 other predicate after a 107-day review. Its family tree reaches back 6 generations to 1996. 14 later devices descend from it.
- Decided
- May 19, 2011
- Review
- 107 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K955348 (1996). 11 ancestors in all, the oldest K933881 (1994). 14 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 5 generations backK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- 4 generations backK070300 Expedium SFX Cross Connector SystemDepuy Spine, Inc. · 2007 · Recalled
- 3 generations backK081153 Novel Spinal SystemMedyssey Co, Ltd. · 2009
- 2 generations backK093104 Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- 1 generation backK103272 Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- This deviceK110283 Zenius Spinal SystemMedyssey Co, Ltd. · 2011
- Descendant · cites it directly · 11 of its ownK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
- Descendant · cites it directly · 8 of its ownK131878 Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK142835 Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK171526 Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013 · cites it directly11descendants
- K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013 · cites it directly8descendants
- K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015 · 2 generations on5descendants
- K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · 3 generations on2descendants
- K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −5 | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| −4 | K070300 | Expedium SFX Cross Connector System | Depuy Spine, Inc. | 2007 | 1 |
| −3 | K081153 | Novel Spinal System | Medyssey Co, Ltd. | 2009 | — |
| −2 | K093104 | Medyssey CO., LTD., Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| −1 | K103272 | Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| 0 (this device) | K110283 | Zenius Spinal System | Medyssey Co, Ltd. | 2011 | — |
| +1 | K121670 | Medyssey Cannulated Pedicle Screw | Medyssey Co, Ltd. | 2013 | — |
| +1 | K131878 | Lliad, Kora, Zenius Pedicle Screw System | Medyssey USA, Inc. | 2013 | — |
| +2 | K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | Medyssey USA, Inc. | 2015 | — |
| +3 | K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023 | — |
| +2 | K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation Systems | Medyssey USA, Inc. | 2017 | — |
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 |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K093104 | Medyssey CO., LTD., Zenius Spinal SystemSummary page 1…al System 3. Device Class ificati on (s): * Pedicle Screw Spinal System - MNI, MNH -21 CFR § 888.3070 4. Predicate Device: Medyssey Co., Ltd., Zen/usm Spinal System (K093104) Medyssey Co., Ltd., Zen/um Spinal System (K1 03272) 5. Device Description: The ZeniusTM Spinal System is a top-loading posterio… | 2010 |
| * | K103272 | Zenius Spinal SystemSummary page 1…cle Screw Spinal System - MNI, MNH -21 CFR § 888.3070 4. Predicate Device: Medyssey Co., Ltd., Zen/usm Spinal System (K093104) Medyssey Co., Ltd., Zen/um Spinal System (K1 03272) 5. Device Description: The ZeniusTM Spinal System is a top-loading posterior spinal fixation system which consists of pedicle s… | 2010 |
What descends from it? (14)
See all 143 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 15 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K121670 (Medyssey Co, Ltd., 2013) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K093104.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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/K110283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110283: Zenius Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110283
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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