510(k) · Cleared
ClearedIliad Pedicle Screw System and 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 Jun 12, 2015 as substantially equivalent to K042025 (Medtronic Sofamor Danek, Inc., 2004) and 4 other predicates after a 255-day review. Its family tree reaches back 11 generations to 1985. 1 of the 159 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jun 12, 2015
- Review
- 255 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K853033 (1985). 153 ancestors in all. 5 later devices descend from it, 2 citing it directly. 1 of the 159 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
- This deviceK142835 Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK171509 Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK250582 COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
- Descendant · 2 generations on · 0 of its ownK181978 Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
- This deviceK142835 Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc. · 2015
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
Most influential descendants
Showing 5 of 5 · See all- K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · cites it directly2descendants
- K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc. · 2017 · cites it directly1descendant
- K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025 · 2 generations on0descendants
- K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023 · 2 generations on0descendants
- K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −1 | K102249 | Expedium Spine System | Depuy Spine, A Johnson & Johnson Company | 2010 | — |
| 0 (this device) | K142835 | Iliad Pedicle Screw System and Zenius Pedicle Screw System | Medyssey USA, Inc. | 2015 | — |
| +1 | K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023 | — |
| +1 | K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System | Medyssey USA, Inc. | 2017 | — |
| +2 | K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | 2025 | — |
| +2 | K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 2023 | — |
| +2 | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 11 | 0 |
| 2005 | 15 | 0 |
| 2006 | 7 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 8 | 1 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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? (5)
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 |
|---|---|---|---|
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 5…n. Predicate Device(s): Medyssey believes these devices are substantially equivalent to predicate devices previously cleared by FDA. The CD Horizon system by Medtronic (K042025) is the primary predicate. Additional predicate devices include the Iliad and Zenius systems (K131878), the Expedium Spine System… | 2004 |
| * | K131878 | Lliad, Kora, Zenius Pedicle Screw SystemSummary page 5…ices previously cleared by FDA. The CD Horizon system by Medtronic (K042025) is the primary predicate. Additional predicate devices include the Iliad and Zenius systems (K131878), the Expedium Spine System by DePuy Spine (K102249), the Optima system by U&I (Zimmer) (K051971), and the Xia system by Stryker… | 2013 |
| * | K102249 | Expedium Spine SystemSummary page 5…m by Medtronic (K042025) is the primary predicate. Additional predicate devices include the Iliad and Zenius systems (K131878), the Expedium Spine System by DePuy Spine (K102249), the Optima system by U&I (Zimmer) (K051971), and the Xia system by Stryker (K001272). Technological Characteristics: The Iliad… | 2010 |
| * | K051971 | Optima Spinal SystemSummary page 5…cate. Additional predicate devices include the Iliad and Zenius systems (K131878), the Expedium Spine System by DePuy Spine (K102249), the Optima system by U&I (Zimmer) (K051971), and the Xia system by Stryker (K001272). Technological Characteristics: The Iliad and Zenius Pedicle Screw Systems share the s… | 2005 |
| * | K001272 | Xia Spine SystemSummary page 5…e the Iliad and Zenius systems (K131878), the Expedium Spine System by DePuy Spine (K102249), the Optima system by U&I (Zimmer) (K051971), and the Xia system by Stryker (K001272). Technological Characteristics: The Iliad and Zenius Pedicle Screw Systems share the same indications for use, design, material… | 2000 |
What descends from it? (5)
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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 153 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K222229 (CG Bio Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 36 other devices also cite its predicate K042025.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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. Iliad Pedicle Screw System and Zenius Pedicle Screw System 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/K142835 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142835: Iliad Pedicle Screw System and Zenius Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142835
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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