510(k) · Cleared
Recalled · 2007Xia Spinal System, Xia 4.5 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 6, 2006 as substantially equivalent to K053115 (Stryker Spine, 2005) and 2 other predicates after a 21-day review. Its family tree reaches back 3 generations to 1995. 1 of the 746 devices in its family, counting itself, has a Class I recall. 734 later devices descend from it. It has been recalled once.
- Decided
- Mar 6, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K950697 (1995). 11 ancestors in all. 734 later devices descend from it, 19 citing it directly. 1 of the 746 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 2 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 1 generation backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- This deviceK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006
- Descendant · cites it directly · 710 of its ownK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- Descendant · 2 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 430 of its ownK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- Descendant · 3 generations on · 337 of its ownK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
Showing 5 of 734 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 734 · See all- K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006 · cites it directly710descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on518descendants
- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on462descendants
- K071373Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · cites it directly430descendants
- K090648Viper 2 SystemDepuy Spine, Inc. · 2009 · 3 generations on337descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −2 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −1 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| 0 (this device) | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | — |
| +1 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| +2 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +1 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| +3 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 11 | 0 |
| 2010 | 10 | 0 |
| 2011 | 12 | 0 |
| 2012 | 29 | 0 |
| 2013 | 31 | 0 |
| 2014 | 26 | 0 |
| 2015 | 37 | 0 |
| 2016 | 33 | 0 |
| 2017 | 54 | 0 |
| 2018 | 51 | 0 |
| 2019 | 46 | 0 |
| 2020 | 46 | 0 |
| 2021 | 36 | 1 |
| 2022 | 45 | 0 |
| 2023 | 69 | 0 |
| 2024 | 64 | 0 |
| 2025 | 60 | 0 |
| 2026 | 55 | 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 |
|---|---|---|---|
| * | K053115 | Xia Spinal SystemSummary page 1…nal Intervertebral Body Fixation Orthosis [21 CFR 888.3060] Product Code KBKWWQ MNH, and NMN Predicate Devices Stryker Spine Xia' Spinal System (K053 115) Stryker Spine Xiao 4.5 Spinal System (K052761) Medtronic Sofamnor Danek's… | 2005 |
| * | K052761 | Modification to: Xia 4.5 Spinal SystemSummary page 1…KBKWWQ MNH, and NMN Predicate Devices Stryker Spine Xia' Spinal System (K053 115) Stryker Spine Xiao 4.5 Spinal System (K052761) Medtronic Sofamnor Danek's CD Horizon System (K032033) Device Description The Xia6 Spinal Sys… | 2005 |
| * | K032033 | CD Horizon Spinal SystemSummary page 1…inal System (K053 115) Stryker Spine Xiao 4.5 Spinal System (K052761) Medtronic Sofamnor Danek's CD Horizon System (K032033) Device Description The Xia6 Spinal System contains the same Stainless Steel and Titanium allo… | 2003 |
What descends from it? (734)
See all 73419 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060979 | Xia Titanium and 4.5 Spinal Systems | 2006 | 710 |
| K071373 | Stryker Spine Xia Iii Spinal System | 2007 | 430 |
| K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | 2006 | 216 |
| K080928 | Xia Spinal System, Stainless Steel Uni-Planar Screws | 2008 | 182 |
| K061813 | Mantis Spinal System | 2006 | 135 |
| K060748 | Modification to Xia 4.5 Spinal System | 2006 | 134 |
| K073151 | Mantis Spinal System | 2007 | 111 |
| K092605 | Xia 4.5 Spinal System | 2009 | 98 |
| K121342 | Xia 4.5 Spinal System | 2012 | 88 |
| K070368 | Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System | 2007 | 87 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2007 | Not classified | Z-1525-2009 | Error in labeling | Labeling Issue: The large Xia Anterior Staple was laser marked with an "S", indicating small. |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K060979 (Stryker Spine, 2006) has gone furthest, with 710 descendants of its own.
- 3 other devices also cite its predicate K053115.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Xia® Spinal System and Xia® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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…
Read the full statement (117 words)
The Xia® Spinal System and Xia® 4.5 Spinal System are intended for anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation 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.
The 6 mm diameter rods from the DIAPASON T M Spinal System and OPUSTM Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia® Titanium Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060361 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060361: Xia Spinal System, Xia 4.5 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/K060361
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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