510(k) · Cleared
ClearedZenius™ Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey USA, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 24, 2023 as substantially equivalent to K093104 (Medyssey Co, Ltd., 2010) and 3 other predicates after a 29-day review. Its family tree reaches back 11 generations to 1999. 1 of the 111 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 24, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K990745 (1999). 110 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet. 1 of the 111 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
- 1 generation backK171526 Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017
- This deviceK232218 Zenius™ Spinal SystemMedyssey USA, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 5 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 4 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
- 1 generation backK171526 Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017
- This deviceK232218 Zenius™ Spinal SystemMedyssey USA, Inc. · 2023
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −5 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −4 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −3 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −2 | K121670 | Medyssey Cannulated Pedicle Screw | Medyssey Co, Ltd. | 2013 | — |
| −1 | K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation Systems | Medyssey USA, Inc. | 2017 | — |
| 0 (this device) | K232218 | Zenius™ Spinal System | Medyssey USA, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 11 | 0 |
| 2004 | 9 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 1 |
| 2011 | 2 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 4…Classification 888.3070 Product Code: NKB Primary Predicate Device: Medyssey USA, Inc. Zenius™ System (K093104) Additional Predicates: Medyssey USA, Inc. Zenius™ System (K103272)… | 2010 |
| * | K103272 | Zenius Spinal SystemSummary page 4…KB Primary Predicate Device: Medyssey USA, Inc. Zenius™ System (K093104) Additional Predicates: Medyssey USA, Inc. Zenius™ System (K103272) Medyssey USA, Inc. Medyssey Cannulated Pedicle… | 2010 |
| * | K121670 | Medyssey Cannulated Pedicle ScrewSummary page 4…Inc. Zenius™ System (K103272) Medyssey USA, Inc. Medyssey Cannulated Pedicle Screw (K121670) Medyssey USA, Inc. Zenius™, Iliad™, and Kora™… | 2013 |
| * | K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation SystemsSummary page 4…ew (K121670) Medyssey USA, Inc. Zenius™, Iliad™, and Kora™ Spinal Fixation Systems (K171526) Device Description: The Zenius™ Spinal System, Internal Fixation Device for Spinal Surgery is comprised of: rods, pedicle scre… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 110 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K093104.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Medyssey Co, Ltd. Zenius Spinal System is intended for posterior, noncervical pedicle fixation as an adjunct to
fusion in skeletally mature patients using autograft and /or allograft for the following indications: degenerative disc
disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and
radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis; curvatures (i.e., scoliosis,
kyphosis, and / or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232218: Zenius™ Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232218
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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