510(k) · Cleared
ClearedNovel Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey Co, Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 30, 2009 as substantially equivalent to K070300 (Depuy Spine, Inc., 2007) and 1 other predicate after a 282-day review. Its family tree reaches back 3 generations to 1996. 23 later devices descend from it.
- Decided
- Jan 30, 2009
- Review
- 282 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955348 (1996). 5 ancestors in all, the oldest K933881 (1994). 23 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 2 generations backK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
- 1 generation backK070300 Expedium SFX Cross Connector SystemDepuy Spine, Inc. · 2007 · Recalled
- This deviceK081153 Novel Spinal SystemMedyssey Co, Ltd. · 2009
- Descendant · cites it directly · 20 of its ownK093104 Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- Descendant · 2 generations on · 15 of its ownK103272 Zenius Spinal SystemMedyssey Co, Ltd. · 2010
- Descendant · 2 generations on · 14 of its ownK110283 Zenius Spinal SystemMedyssey Co, Ltd. · 2011
- Descendant · cites it directly · 13 of its ownK103147 Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd. · 2010
- Descendant · cites it directly · 12 of its ownK110284 Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd. · 2010 · cites it directly20descendants
- K103272Zenius Spinal SystemMedyssey Co, Ltd. · 2010 · 2 generations on15descendants
- K110283Zenius Spinal SystemMedyssey Co, Ltd. · 2011 · 2 generations on14descendants
- K103147Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd. · 2010 · cites it directly13descendants
- K110284Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd. · 2011 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −2 | K062196 | SFX Snap-Fit Cross Connector | Depuy Spine, Inc. | 2006 | — |
| −1 | K070300 | Expedium SFX Cross Connector System | Depuy Spine, Inc. | 2007 | 1 |
| 0 (this device) | K081153 | Novel Spinal System | Medyssey Co, Ltd. | 2009 | — |
| +1 | K093104 | Medyssey CO., LTD., Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| +2 | K103272 | Zenius Spinal System | Medyssey Co, Ltd. | 2010 | — |
| +2 | K110283 | Zenius Spinal System | Medyssey Co, Ltd. | 2011 | — |
| +1 | K103147 | Novel Iii Spinal Fixation and Adjustable Bridge System | Medyssey Co, Ltd. | 2010 | — |
| +1 | K110284 | Novel Iii Spinal Fixation and Adjustable Bridge System | Medyssey Co, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K070300 | Expedium SFX Cross Connector SystemSummary page 3…fication. Predicate Devices -The subject device is substantially equivalent to the following predicate devices: * ISOLA Spine System (DePuy Spine, Inc; K070300) *'DenaliSpinal System (K2M, LLC, K042635) Comparison to Predicate Devices… | 2007 |
| * | K042635 | Denali Spine SystemSummary page 3…-The subject device is substantially equivalent to the following predicate devices: * ISOLA Spine System (DePuy Spine, Inc; K070300) *'DenaliSpinal System (K2M, LLC, K042635) Comparison to Predicate Devices Syste… | 2005 |
What descends from it? (23)
See all 235 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093104 | Medyssey CO., LTD., Zenius Spinal System | 2010 | 20 |
| K103147 | Novel Iii Spinal Fixation and Adjustable Bridge System | 2010 | 13 |
| K110284 | Novel Iii Spinal Fixation and Adjustable Bridge System | 2011 | 12 |
| K121670 | Medyssey Cannulated Pedicle Screw | 2013 | 11 |
| K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation Systems | 2017 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K093104 (Medyssey Co, Ltd., 2010) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K070300.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Novel Spinal System 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 Novel Spinal System is intended to provide immobilization and stabilization of spinal…
Read the full statement (121 words)
The Novel Spinal System 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 Novel Spinal 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/K081153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081153: Novel 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/K081153
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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