510(k) · Cleared
ClearedZenius™, lliad™ and Kora™ Spinal Fixation Systems
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 21, 2017 as substantially equivalent to K121670 (Medyssey Co, Ltd., 2013) and 5 other predicates after an 88-day review. Its family tree reaches back 10 generations to 1999. 1 of the 112 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Aug 21, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K990745 (1999). 109 ancestors in all, the oldest K933881 (1994). 2 later devices descend from it, 2 citing it directly. 1 of the 112 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
- This deviceK171526 Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK232218 Zenius™ Spinal SystemMedyssey USA, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK181978 Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 4 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK121670 Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
- This deviceK171526 Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2017
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −4 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −3 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −2 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −1 | K121670 | Medyssey Cannulated Pedicle Screw | Medyssey Co, Ltd. | 2013 | — |
| 0 (this device) | K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation Systems | Medyssey USA, Inc. | 2017 | — |
| +1 | K232218 | Zenius™ Spinal System | Medyssey USA, Inc. | 2023 | — |
| +1 | K181978 | Zenius™, Iliad™ and Kora™ Spinal Fixation Systems | Medyssey USA, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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.
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? (6)
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 |
|---|---|---|---|
| * | K121670 | Medyssey Cannulated Pedicle ScrewSummary page 4… Medyssey: Iliad Pedicle Screws (formerly Novel) Kora Pedicle Screws (formerly Novel Standard Buttress Thread Screw) Zenius Pedicle Screws Cobalt Chrome Rods – K121670(Cleared 1/25/2013) Additional Predicate Devices: Medyssey: Zenius Pedical Screws and Titanium Rods – K093104 (Cleared… | 2013 |
| * | K093104 | Medyssey CO., LTD., Zenius Spinal SystemSummary page 4…Screw) Zenius Pedicle Screws Cobalt Chrome Rods – K121670(Cleared 1/25/2013) Additional Predicate Devices: Medyssey: Zenius Pedical Screws and Titanium Rods – K093104 (Cleared 6/25/2000) and K103272 (Cleared 12/29/2010) Medyssey: Novel Pedicle Screws and Titanium Rods – K081153 (Cle… | 2010 |
| * | K103272 | Zenius Spinal SystemSummary page 4…alt Chrome Rods – K121670(Cleared 1/25/2013) Additional Predicate Devices: Medyssey: Zenius Pedical Screws and Titanium Rods – K093104 (Cleared 6/25/2000) and K103272 (Cleared 12/29/2010) Medyssey: Novel Pedicle Screws and Titanium Rods – K081153 (Cleared 1/30/2009), K103147… | 2010 |
| * | K081153 | Novel Spinal SystemSummary page 4…y: Zenius Pedical Screws and Titanium Rods – K093104 (Cleared 6/25/2000) and K103272 (Cleared 12/29/2010) Medyssey: Novel Pedicle Screws and Titanium Rods – K081153 (Cleared 1/30/2009), K103147 (Cleared 12/16/2010), and K110284 (Cleared 6/8/2011)… | 2009 |
| * | K103147 | Novel Iii Spinal Fixation and Adjustable Bridge SystemSummary page 4…Titanium Rods – K093104 (Cleared 6/25/2000) and K103272 (Cleared 12/29/2010) Medyssey: Novel Pedicle Screws and Titanium Rods – K081153 (Cleared 1/30/2009), K103147 (Cleared 12/16/2010), and K110284 (Cleared 6/8/2011)… | 2010 |
| * | K110284 | Novel Iii Spinal Fixation and Adjustable Bridge SystemSummary page 4…0) and K103272 (Cleared 12/29/2010) Medyssey: Novel Pedicle Screws and Titanium Rods – K081153 (Cleared 1/30/2009), K103147 (Cleared 12/16/2010), and K110284 (Cleared 6/8/2011)… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 109 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232218 (Medyssey USA, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121670.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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™, lliad™ and Kora™ Spinal Fixation Systems are 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 as stated in the FDA summary.
https://510kreport.com/device/K171526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171526: Zenius™, lliad™ and Kora™ Spinal Fixation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171526
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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