510(k) · Cleared
ClearedLliad, Kora, Zenius Pedicle Screw 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 23, 2013 as substantially equivalent to K121670 (Medyssey Co, Ltd., 2013) and 2 other predicates after a 60-day review. Its family tree reaches back 10 generations to 1999. 1 of the 118 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Aug 23, 2013
- Review
- 60 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K990745 (1999). 109 ancestors in all, the oldest K933881 (1994). 8 later devices descend from it, 3 citing it directly. 1 of the 118 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 deviceK131878 Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK142835 Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK171509 Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK250582 COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
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 deviceK131878 Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 5 of 8 · See all- K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015 · cites it directly5descendants
- K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · 2 generations on2descendants
- K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc. · 2017 · 2 generations on1descendant
- K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025 · 3 generations on0descendants
- K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023 · 3 generations on0descendants
View 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) | K131878 | Lliad, Kora, Zenius Pedicle Screw System | Medyssey USA, Inc. | 2013 | — |
| +1 | K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | Medyssey USA, Inc. | 2015 | — |
| +2 | K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023 | — |
| +2 | K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System | Medyssey USA, Inc. | 2017 | — |
| +3 | K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | 2025 | — |
| +3 | K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 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.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121670 | Medyssey Cannulated Pedicle ScrewSummary page 2…alloy per ASTM F1537. Predicate Device(s): The Medyssey Pedicle Screw Systems are substantially equivalent to the Zenius, Iliad and Kora pedicle screw systems found in K121670, K110283 and K110284. Performance Standards: The additional components being added in this submission do not represent a new wor… | 2013 |
| * | K110283 | Zenius Spinal SystemSummary page 2…r ASTM F1537. Predicate Device(s): The Medyssey Pedicle Screw Systems are substantially equivalent to the Zenius, Iliad and Kora pedicle screw systems found in K121670, K110283 and K110284. Performance Standards: The additional components being added in this submission do not represent a new worst case.… | 2011 |
| * | K110284 | Novel Iii Spinal Fixation and Adjustable Bridge SystemSummary page 2…. Predicate Device(s): The Medyssey Pedicle Screw Systems are substantially equivalent to the Zenius, Iliad and Kora pedicle screw systems found in K121670, K110283 and K110284. Performance Standards: The additional components being added in this submission do not represent a new worst case. Therefore, n… | 2011 |
What descends from it? (8)
3 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 14 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, K142835 (Medyssey USA, Inc., 2015) has gone furthest, with 5 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. 2013, 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, Iliad and Kora Spinal 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 (ODD) (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 lordlosis); tumor; pseudloarthrosis; and failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131878: Lliad, Kora, Zenius Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131878
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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